CLINICAL POLICY Department: Medical Management Document Name: Opdivo Reference Number: CP.PHAR.121 Effective Date: 07/15
|
|
- Madeleine Payne
- 8 years ago
- Views:
Transcription
1 Page: 1 of 6 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted standards of medical practice, peerreviewed medical literature, government agency/program approval status, and other indicia of medical necessity. The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit determinations should be based on the applicable contract provisions governing plan benefits ( Benefit Plan Contract ) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control. Clinical policies are intended to be reflective of current scientific research and clinical thinking. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. Subject Medical necessity criteria for Opdivo (nivolumab) Description The intent of the criteria is to ensure that patients follow selection elements established by Centene medical policy for Opdivo. FDA-Approved Indications and Limitations of Use 1 Unresectable or Metastatic Melanoma Opdivo is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Metastatic Squamous n-small Cell Lung Cancer Opdivo is indicated for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Limitations of Use: The safety and effectiveness of Opdivo have not been established in pediatric patients.
2 Page: 2 of 6 Policy/Criteria It is the policy of health plans affiliated with Centene Corporation that Opdivo is medically necessary for members meeting the following criteria: Figure 1: Opdivo Algorithm Figure 1: Opdivo Algorithm Currently receiving through a Centene benefit? Experiencing unacceptable toxicity (App. B) or disease progression? Approve for 6 months Age 18 years? Unresectable or metastatic melanoma What is the diagnosis? Other Metastatic Squamous NSCLC Tested for BRAF V600 mutation? Had progression on or after platinumbased chemotherapy (App. A)? BRAF V600 mutation positive? Experienced disease progression following ipilimumab therapy? Currently receiving prescribed regimen? Approve for 3 months Experienced disease progressoin following a BRAF inhibitor therapy (e.g., Zelboarf, Tafinlar)? Experiencing unacceptable toxicity (App. B) or disease progression? Approve for 6 months
3 Page: 3 of 6 Background Opdivo mechanism of action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells inhibits T- cell proliferation and cytokine production. 1 Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. 1 Opdivo is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. 1 In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. 1 Unresectable or metastatic melanoma Opdivo is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Melanoma accounts for less than 2% of skin cancer cases but causes a large majority of skin cancer deaths. 2 The American Cancer Society estimates that in 2015 approximately 73,870 new melanomas will be diagnosed and 9,940 deaths will occur in the United States as a result of melanoma. 2 The median age at diagnosis of melanoma is 59 years. 3 The American Joint Committee of Cancer (AJCC) categorizes patients with melanoma into three groups: 1) localized disease with no evidence of metastases (stage I-II), 2) regional disease (stage III), and 3) distant metastatic disease (stage IV). 3 It is estimated that 82% to 85% of patients with melanoma present with localized disease, 10% to 13% with regional disease, and 2% to 5% with distant metastatic disease. Depending on the stage at presentation, five-year survival rates range from 10% to 90%. 3 Treatment options for melanoma include surgery, radiation and systemic therapy. 3 Surgical excision plays a prominent role in earlier stages of melanoma while systemic therapy and radiation become relatively more central for patients with unresectable or metastatic melanoma. 3 In its March, 2015, melanoma treatment guidelines, the National Comprehensive Cancer Network (NCCN) added Opdivo to its list of preferred regimens for advanced or metastatic melanoma. Additionally, Opdivo s FDA-approved indication for advanced melanoma includes cases that also are BRAF V600 mutation positive. 1 Approximately half of patients with metastatic melanoma have an activating mutation of the intracellular signaling kinase, BRAF. 3 BRAF V600 mutations account for the majority of BRAF mutations found in all patients with cancer. 4 Metastatic Squamous NSCLC Opdivo is indicated for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy (e.g., cisplatin, carboplatin). 1
4 Page: 4 of 6 Lung cancer is the leading cause of cancer death in the United States. 5 In 2015, an estimated 221,200 new cases of lung and bronchial cancer will be diagnosed, and 158,040 deaths are estimated to occur because of the disease. 5 Only 16.8% of all patients with lung cancer are alive five years or more after diagnosis. 5 Lung cancer is divided into two classes based on its biology, therapy and prognosis: NSCLC which accounts for 85% of all lung cancer cases, and small cell lung cancer. 5 NSCLC includes two major types: 1) non-squamous carcinoma (including adenocarcinoma, large-cell carcinoma, and other cell types); and 2) squamous cell (epidermoid) carcinoma. 5 Adenocarcinoma is the most common type of lung cancer seen in the U.S., including among non-smokers. 5 Areas of focus in the diagnosis and approach to lung cancer include minimally invasive techniques for diagnosis and treatment, advances in radiation therapy, and development of targeted therapies such as Opdivo. 1,5 Safety The Opdivo package insert lists no contraindications. 1 Examples of platinum-based chemotherapy regimens are presented at Appendix A. Conditions associated with Opdivo use for which permanent discontinuation is recommended are outlined in Appendix B. Opdivo warnings and precautions are listed in Appendix C. The package insert contain additional information on dose adjustments, drug/drug interactions and use in special populations. Appendices Appendix A: Examples of Platinum-based Chemotherapy Regimens for NSCLC 5 Carboplatin (platinum agent)/paclitaxel Cisplatin (platinum agent)/paclitaxel Appendix B: Immune Mediated Adverse Reactions for which Permanent Discontinuation is Recommended 1 Severe (Grade 3) or life-threatening (Grade 4) pneumonitis Grade 4 colitis or for recurrent colitis upon restarting Opdivo Severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis Life-threatening (Grade 4) serum creatinine elevation Severe (Grade 3) or moderate (Grade 2) serum creatinine elevation if worsening or no improvement after withholding Opdivo and administering corticosteroids Appendix C: Opdivo - Warnings and Precautions 1 Adverse Reaction Warning and Precautions Monitor patients for signs and symptoms of pneumonitis. Administer pneumonitis corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for Grade 2 or greater pneumonitis, followed by corticosteroid taper. Permanently discontinue Opdivo for severe (Grade 3) or life-threatening
5 Page: 5 of 6 Adverse Reaction colitis hepatitis nephritis and renal dysfunction hypothyroidism and hyperthyroidism Other immunemediated adverse Reactions Warning and Precautions (Grade 4) pneumonitis and withhold Opdivo until resolution for moderate (Grade 2) pneumonitis. Monitor patients for immune-mediated colitis. Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for severe (Grade 3) or life-threatening (Grade 4) colitis. Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day prednisone equivalents followed by corticosteroid taper for moderate (Grade 2) colitis of more than 5 days duration; if worsening or no improvement occurs despite initiation of corticosteroids, increase dose to 1 to 2 mg/kg/day prednisone equivalents. Withhold Opdivo for Grade 2 or 3 immune-mediated colitis. Permanently discontinue Opdivo for Grade 4 colitis or for recurrent colitis upon restarting Opdivo Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for Grade 2 or greater transaminase elevations, with or without concomitant elevation in total bilirubin. Withhold Opdivo for moderate (Grade 2) and permanently discontinue Opdivo for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by corticosteroid taper for lifethreatening (Grade 4) serum creatinine elevation and permanently discontinue Opdivo. For severe (Grade 3) or moderate (Grade 2) serum creatinine elevation, withhold Opdivo and administer corticosteroids at a dose of 0.5 to 1 mg/kg/day prednisone equivalents followed by corticosteroid taper; if worsening or no improvement occurs, increase dose of corticosteroids to 1 to 2 mg/kg/day prednisone equivalents and permanently discontinue Opdivo. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. There are no recommended dose adjustments of Opdivo for hypothyroidism or hyperthyroidism. For any suspected immune-mediated adverse reactions, exclude other causes. Based on the severity of the adverse reaction, withhold Opdivo, administer high-dose corticosteroids, and if appropriate, initiate hormonereplacement therapy. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider restarting Opdivo after completion of corticosteroid taper based on the
6 Page: 6 of 6 Adverse Reaction Embryo fetal toxicity Warning and Precautions severity of the event. Based on its mechanism of action and data from animal studies, Opdivo can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Opdivo and for at least 5 months after the last dose of Opdivo. References 1. Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb; March American Cancer Society. What are key statistics about melanoma skin cancer? Available at: Accessed June The National Comprehensive Cancer Network. The NCCN Clinical Practice Guidelines in Oncology: Melanoma (Version ). Available at: Accessed June Flaherty KT, Robert C, Hersey P, et al. Improved Survival with MEK Inhibition in BRAF- Mutated Melanoma. N Engl J Med.2012;367(2): National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: n-small Cell Lung Cancer (Version ). Available at Accessed June Revision Log Date 2014 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation.
CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early
April 21, 2015 CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early Opdivo Demonstrates Superior Overall Survival Compared to Docetaxel in Patients with Previously-Treated
More informationAttached from the following page is the press release made by BMS for your information.
July 22, 2015 CheckMate -025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early (PRINCETON, NJ, July 20, 2015) Bristol-Myers Squibb Company (NYSE:BMY) announced
More informationAnti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma. Claire Vines, 2016 Pharm.D. Candidate
+ Anti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma Claire Vines, 2016 Pharm.D. Candidate + Disclosure I have no conflicts of interest to disclose. + Objectives Summarize NCCN
More informationCancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing)
Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015 (minutes for web publishing) Cancer Treatments Subcommittee minutes are published in accordance with the Terms of Reference for the
More informationOpdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Advanced Form of Bladder Cancer
June 28, 2016 Opdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Advanced Form of Bladder Cancer (PRINCETON, NJ, June 27, 2016) - Bristol-Myers Squibb
More informationMedia Contacts: Annick Robinson Investor Contacts: Teri Loxam (438) 837-2550 (908) 740-1986
News Release Media Contacts: Annick Robinson Investor Contacts: Teri Loxam (438) 837-2550 (908) 740-1986 Merck Announces Initial Results for Pembrolizumab with Novel Immunotherapy Combinations from Three
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline: PS Inj - Alimta Therapeutic Class: Antineoplastic Agents Therapeutic Sub-Class: Antifolates Client: PS Inj Approval Date: 8/2/2004 Revision Date: 12/5/2006 I. BENEFIT
More informationKEYTRUDA (pembrolizumab) for injection, for intravenous use KEYTRUDA (pembrolizumab) injection, for intravenous use Initial U.S.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. See full prescribing information for KEYTRUDA. KEYTRUDA (pembrolizumab)
More informationKEYTRUDA (pembrolizumab) for injection, for intravenous use KEYTRUDA (pembrolizumab) injection, for intravenous use Initial U.S.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. See full prescribing information for KEYTRUDA. KEYTRUDA (pembrolizumab)
More informationWhat You Need to Know About Lung Cancer Immunotherapy
What You Need to Know About Lung Cancer Immunotherapy Lung.org/immunotherapy What is immunotherapy? Immunotherapy for cancer, sometimes called immune-oncology, is a type of medicine that treats cancer
More informationFoundational Issues Related to Immunotherapy and Melanoma
Transcript Details This is a transcript of a continuing medical education (CME) activity accessible on the ReachMD network. Additional media formats for the activity and full activity details (including
More informationRecruiting now. Could you help by joining this study?
Non-Small Cell Lung Cancer Recruiting now AstraZeneca is looking for men and women with locally advanced or metastatic non-small cell lung cancer (NSCLC) to join ATLANTIC, a clinical study to help investigate
More informationPOLICY A. INDICATIONS
Alimta (pemetrexed) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 09/01/2007 Current Effective Date: 10/01/2015 POLICY A. INDICATIONS The indications below
More informationCLINICAL POLICY Department: Medical Management Document Name: Vivitrol Reference Number: NH.PHAR.96 Effective Date: 03/12
Page: 1 of 7 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted
More informationTargeted Therapy What the Surgeon Needs to Know
Targeted Therapy What the Surgeon Needs to Know AATS Focus in Thoracic Surgery 2014 David R. Jones, M.D. Professor & Chief, Thoracic Surgery Memorial Sloan Kettering Cancer Center I have no disclosures
More informationThis regimen has low emetogenic potential refer to local protocol None required routinely. Baseline results valid for 7 days. Results valid for 72 hrs
Regimen : Ipilimumab for Advanced Melanoma ICD10 code Codes pre-fixed with C43. Indication Regimen detail Ipilimumab is recommended as an option for treating advanced (unresectable or metastatic) melanoma
More informationCetuximab (Erbitux) MM.04.005 05/10/2005. HMO; PPO; QUEST Integration 01/01/2015 Section: Prescription Drugs Place(s) of Service: Office: Outpatient
Cetuximab (Erbitux) Policy Number: Original Effective Date: MM.04.005 05/10/2005 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 01/01/2015 Section: Prescription Drugs Place(s)
More informationCorporate Medical Policy
Corporate Medical Policy Ado-Trastuzumab Emtansine (Trastuzumab-DM1) for Treatment of File Name: Origination: Last CAP Review: Next CAP Review: Last Review: ado_trastuzumab_emtansine_(trastuzumab-dm1)_for_treatment_of_her-2_positivemalignancies
More informationTreatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost-Effectiveness
Department of Veterans Affairs Health Services Research & Development Service Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost-Effectiveness
More informationThe following information is only meant for people who have been diagnosed with advanced non-small cell
Important information for people with advanced non-small cell lung cancer The following information is only meant for people who have been diagnosed with advanced non-small cell lung cancer (NSCLC). NSCLC
More informationCorporate Medical Policy
Corporate Medical Policy Molecular Analysis for Targeted Therapy for Non-Small Cell Lung File Name: Origination: Last CAP Review: Next CAP Review: Last Review: molecular_analysis_for_targeted_therapy_for_non_small_cell_lung_cancer
More informationMaintenance therapy in in Metastatic NSCLC. Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai
Maintenance therapy in in Metastatic NSCLC Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai Definition of Maintenance therapy The U.S. National Cancer Institute s
More informationBCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA)
BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA) Protocol Code Tumour Group Contact Physician UBRAVKAD Breast Dr Stephen Chia ELIGIBILITY:
More informationGUIDELINES FOR THE MANAGEMENT OF LUNG CANCER
GUIDELINES FOR THE MANAGEMENT OF LUNG CANCER BY Ali Shamseddine, MD (Coordinator); as04@aub.edu.lb Fady Geara, MD Bassem Shabb, MD Ghassan Jamaleddine, MD CLINICAL PRACTICE GUIDELINES FOR THE TREATMENT
More informationOvarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development
Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development Sanjeeve Bala, MD, MPH Ovarian Cancer Endpoints Workshop FDA White Oak September 3, 2015 Overview Immune agents from
More informationSummary of treatment benefits
Risk Management Plan PEMETREXED Powder for concentrate for Solution for infusion Pemetrexed is also indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non small cell
More informationYour Immune System & Lung Cancer Treatment
Your Immune System & Lung Cancer Treatment Immunotherapy and Lung Cancer Immunotherapy is quickly developing as an important approach to treating many forms of cancer, including lung cancer. Immunotherapy
More informationUpdate in Hematology Oncology Targeted Therapies. Mark Holguin
Update in Hematology Oncology Targeted Therapies Mark Holguin 25 years ago Why I chose oncology People How to help people with possibly the most difficult thing they may have to deal with Science Turning
More information5.07.09. Aubagio. Aubagio (teriflunomide) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.07.09 Subject: Aubagio Page: 1 of 6 Last Review Date: December 5, 2014 Aubagio Description Aubagio (teriflunomide)
More informationUnderstanding series. new. directions. 1-800-298-2436 LungCancerAlliance.org. A guide for the patient
Understanding series LUNG CANCER: new treatment directions 1-800-298-2436 LungCancerAlliance.org A guide for the patient TABLE OF CONTENTS What s New in lung cancer? Advancements...4 Changes in genes that
More informationComparing Immunotherapy with High Dose IL-2 and Ipilimumab
Comparing Immunotherapy with High Dose IL-2 and Ipilimumab Michael K Wong MD PhD FRCPC mike.wong@med.usc.edu Disclosures Speaker s Bureau, Advisory Boards, Consultant: Prometheus Bristol Myers Squibb Novartis
More informationINITIATING ORAL AUBAGIO (teriflunomide) THERAPY
FOR YOUR PATIENTS WITH RELAPSING FORMS OF MS INITIATING ORAL AUBAGIO (teriflunomide) THERAPY WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY Severe liver injury including fatal liver failure has been
More informationAvastin in breast cancer: Summary of clinical data
Avastin in breast cancer: Summary of clinical data Worldwide, over one million people are diagnosed with breast cancer every year 1. It is the most frequently diagnosed cancer in women 1,2, and the leading
More informationGoals and Objectives: Breast Cancer Service Department of Radiation Oncology
Goals and Objectives: Breast Cancer Service Department of Radiation Oncology The breast cancer service provides training in the diagnosis, management, treatment, and follow-up of breast malignancies, including
More informationGenomic Medicine The Future of Cancer Care. Shayma Master Kazmi, M.D. Medical Oncology/Hematology Cancer Treatment Centers of America
Genomic Medicine The Future of Cancer Care Shayma Master Kazmi, M.D. Medical Oncology/Hematology Cancer Treatment Centers of America Personalized Medicine Personalized health care is a broad term for interventions
More informationIMMUNOTHERAPY FOR THE TREATMENT OF LUNG CANCER
IMMUNOTHERAPY FOR THE TREATMENT OF LUNG CANCER BOOKLET SUPPLEMENT Immunotherapy Immunotherapy is one of the most exciting new approaches for treating several types of cancer, including lung cancer. Immunotherapies
More informationCorporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: hematopoietic_stem-cell_transplantation_for_epithelial_ovarian_cancer 2/2001 11/2015 11/2016 11/2015 Description
More informationImmuno-Oncology Therapies to Treat Lung Cancer
Immuno-Oncology Therapies to Treat Lung Cancer What you need to know ONCHQ14NP07519 Introduction: Immuno-oncology represents an innovative approach to cancer research that seeks to harness the body s own
More informationTreatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness
Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness Investigators: Paul G. Shekelle, MD, PhD, Director Alicia R. Maher, MD Clinical
More informationYour Immune System & Melanoma Treatment
Your Immune System & Melanoma Treatment Immunotherapy and Melanoma Immunotherapy is rapidly emerging as an important approach to treating many forms of cancer. For people with melanoma, the news is particularly
More informationReport series: General cancer information
Fighting cancer with information Report series: General cancer information Eastern Cancer Registration and Information Centre ECRIC report series: General cancer information Cancer is a general term for
More informationAdditional 50 patients enrolled in KEYNOTE-001 with analyses planned using Merck s proprietary PD-L1 assay at one percent and 50 percent cut points
News Release Media Contacts: Annick Robinson Dominique Quirion Merck NATIONAL Annick.robinson@merck.com dquirion@national.ca 514 428-2890 514 843-2302 Investor Contacts: Justin Holko: (+1 908-423-5088
More informationTreating Patients with Hormone Receptor Positive, HER2 Positive Operable or Locally Advanced Breast Cancer
Breast Studies Adjuvant therapy after surgery Her 2 positive Breast Cancer B 52 Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients with Hormone
More informationBefore, Frank's immune cells could
Before, Frank's immune cells could barely recognize a prostate cancer cell. Now, they are focused on it. Stimulate an immune response against advanced prostate cancer Extend median survival beyond 2 years
More informationMetastatic Breast Cancer 201. Carolyn B. Hendricks, MD October 29, 2011
Metastatic Breast Cancer 201 Carolyn B. Hendricks, MD October 29, 2011 Overview Is rebiopsy necessary at the time of recurrence or progression of disease? How dose a very aggressive treatment upfront compare
More informationCLINICAL POLICY Department: Medical Management Document Name: HER2 Breast Cancer Treatments
Page: 1 of 11 Specialist Review: Revised: 06/13 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review
More informationReimbursement BILLING GUIDE
Reimbursement BILLING GUIDE Merck has developed this Reimbursement Billing Guide as a tool to help you navigate the health care insurance environment for KEYTRUDA. IMPORTANT INFORMATION CONTENTS The information
More informationEmerging Drug List GEFITINIB
Generic (Trade Name): Manufacturer: Gefitinib (Iressa ) formerly referred to as ZD1839 AstraZeneca NO. 52 JANUARY 2004 Indication: Current Regulatory Status: Description: Current Treatment: Cost: Evidence:
More informationASCO 12. PD-1 Immunotherapy Makes a Splash at ASCO
PD-1 Immunotherapy Makes a Splash at ASCO By Gregory R. Wolfe, PhD Epigenetic variation and genetic instability in tumor cells yield a variety of tumor antigens that the immune system can recognize to
More informationLung Cancer Research: From Prevention to Cure!
Lung Cancer Research: From Prevention to Cure! Ravi Salgia, M.D, Ph.D Associate Professor of Medicine Director, Thoracic Oncology Research Program Department of Medicine Section of Hematology/Oncology
More informationBREAST CANCER UPDATE C H R I S S Z Y A R T O, D O G E N E S E E H E M A T O L O G Y O N C O L O G Y F L I N T, M I
BREAST CANCER UPDATE C H R I S S Z Y A R T O, D O G E N E S E E H E M A T O L O G Y O N C O L O G Y F L I N T, M I Overview Why is it important to understand breast cancer? Choosing wisely Appropriateness
More informationOncos Therapeutics: ONCOS THERAPEUTICS Personalized Cancer Immunotherapy. March 2015. Antti Vuolanto, COO and co-founder
Oncos Therapeutics: Personalized Cancer Immunotherapy ONCOS THERAPEUTICS Personalized Cancer Immunotherapy March 2015 Antti Vuolanto, COO and co-founder 1 History of Oncos Therapeutics 2002 2007 2009 Research
More informationActivity of pemetrexed in thoracic malignancies
Activity of pemetrexed in thoracic malignancies Results of phase III clinical studies of pemetrexed in malignant pleural mesothelioma and non-small cell lung cancer show benefit P emetrexed (Alimta) is
More informationCancer Treatments Subcommittee of PTAC Meeting held 2 March 2012. (minutes for web publishing)
Cancer Treatments Subcommittee of PTAC Meeting held 2 March 2012 (minutes for web publishing) Cancer Treatments Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology
More informationLUNG CANCER TREATMENTS. What you need to know about... immunotherapy
LUNG CANCER TREATMENTS What you need to know about... immunotherapy foreword About LUNGevity LUNGevity is the largest national lung cancer-focused nonprofit, changing outcomes for people with lung cancer
More informationREFERENCE CODE GDHC212DFR PUBLICAT ION DATE JUNE 2013 GSK1572932A (NON-SMALL CELL LUNG CANCER) FORECAST AND MARKET ANALYSIS TO 2022
REFERENCE CODE GDHC212DFR PUBLICAT ION DATE JUNE 2013 GSK1572932A (NON-SMALL CELL LUNG CANCER) GSK1572932A (NON-SMALL CELL LUNG CANCER) - Executive Summary GSK1572932A (MAGE-A3): Key Metrics in NSCLC Markets
More informationThe Past, Present & Future of Cancer Immunotherapy:
Article The Past, Present & Future of Cancer Immunotherapy: An Overview Recently BioWorld called cancer immunotherapy white hot based on unprecedented investments in private companies, partnerships between
More informationCarcinoma of the vagina is a relatively uncommon disease, affecting only about 2,000 women in
EVERYONE S GUIDE FOR CANCER THERAPY Malin Dollinger, MD, Ernest H. Rosenbaum, MD, Margaret Tempero, MD, and Sean Mulvihill, MD 4 th Edition, 2001 Vagina Jeffrey L. Stern, MD Carcinoma of the vagina is
More informationMetastatic Melanoma What You Need to Know
ESSENTIALS Metastatic Melanoma Metastatic Melanoma What You Need to Know If you have metastatic melanoma, you may feel as though your life has been turned upside down. It s a serious disease, but patients
More informationGuidance for Industry
Guidance for Industry Cancer Drug and Biological Products Clinical Data in Marketing Applications U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and
More informationLung Cancer: More than meets the eye
Lung Cancer Education Program November 23, 2013 Lung Cancer: More than meets the eye Shantanu Banerji MD, FRCPC Presenter Disclosure Faculty: Shantanu Banerji Relationships with commercial interests: Grants/Research
More informationBREAST CANCER AWARENESS FOR WOMEN AND MEN by Samar Ali A. Kader. Two years ago, I was working as a bedside nurse. One of my colleagues felt
Ali A. Kader, S. (2010). Breast cancer awareness for women and men. UCQ Nursing Journal of Academic Writing, Winter 2010, 70 76. BREAST CANCER AWARENESS FOR WOMEN AND MEN by Samar Ali A. Kader Two years
More informationWhat s New With HER2?
What s New With HER2? Trastuzumab emtansine and pertuzumab for metastatic breast cancer Lindsay Livingston Pharmacist CancerCare Manitoba October 3, 2014 Presenter Disclosure Faculty: Lindsay Livingston
More information5.04.20. Perjeta. Perjeta (pertuzumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.04.20 Subject: Perjeta Page: 1 of 5 Last Review Date: June 19, 2015 Perjeta Description Perjeta (pertuzumab)
More informationCombination Immunotherapies: Melanoma
Combination Immunotherapies: Melanoma Igor Puzanov, MD, MSCI, FACP Associate Professor of Medicine, Associate Director of Phase I Drug Development, Director, Melanoma Research, Clinical Director, Renal
More information18.5 Percent Overall Response Rate Observed in Pembrolizumab-Treated Patients with this Aggressive Form of Breast Cancer
News Release Media Contacts: Annick Robinson Investor Contacts: Joseph Romanelli (514) 837-2550 (908) 740-1986 Stephanie Lyttle NATIONAL Public Relations (514) 843-2365 Justin Holko (908) 740-1879 Merck
More informationNEW CLINICAL RESEARCH OPTIONS IN PANCREATIC CANCER IMMUNOTHERAPY. Alan Melcher Professor of Clinical Oncology and Biotherapy Leeds
NEW CLINICAL RESEARCH OPTIONS IN PANCREATIC CANCER IMMUNOTHERAPY Alan Melcher Professor of Clinical Oncology and Biotherapy Leeds CANCER IMMUNOTHERAPY - Breakthrough of the Year in Science magazine 2013.
More informationNon Small Cell Lung Cancer: Scientific Discoveries and the Pursuit of Progress
Non Small Cell Lung Cancer: Scientific Discoveries and the Pursuit of Progress Lung Cancer Accounts for 14% of All New Cancer Diagnoses in the United States 1 Lung cancer is the second most common malignancy
More informationBiologic Treatments for Rheumatoid Arthritis
Biologic Treatments Rheumatoid Arthritis (also known as cytokine inhibitors, TNF inhibitors, IL 1 inhibitor, or Biologic Response Modifiers) Description Biologics are new class of drugs that have been
More informationEquity markets Major advances in cancer therapeutics 18 August 2015
Major advances in cancer therapeutics 18 August 2015 CIO WM Research Jerome Brimeyer, Equity Sector Strategist, jerome.brimeyer@ubs.com Our cancer therapeutics investment theme recommends companies that
More informationActive centers: 2. Number of patients/subjects: Planned: 20 Randomized: Treated: 20 Evaluated: Efficacy: 13 Safety: 20
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov
More informationNational Horizon Scanning Centre. Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer. December 2007
Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search.
More informationGuidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationImmunotherapy Concept Turned Reality
Authored by: Jennifer Dolan Fox, PhD VirtualScopics Inc. jennifer_fox@virtualscopics.com +1 585 249 6231 Immunotherapy Concept Turned Reality Introduction While using the body s own immune system as a
More informationSmall Cell Lung Cancer
Small Cell Lung Cancer Types of Lung Cancer Non-small cell carcinoma (NSCC) (87%) Adenocarcinoma (38%) Squamous cell (20%) Large cell (5%) Small cell carcinoma (13%) Small cell lung cancer is virtually
More informationFrequently Asked Questions About Ovarian Cancer
Media Contact: Gerri Gomez Howard Cell: 303-748-3933 gerri@gomezhowardgroup.com Frequently Asked Questions About Ovarian Cancer What is ovarian cancer? Ovarian cancer is a cancer that forms in tissues
More informationMOLOGEN AG. Q1 Results 2015 Conference Call Dr. Matthias Schroff Chief Executive Officer. Berlin, 12 May 2015
Q1 Results 2015 Conference Call Dr. Matthias Schroff Chief Executive Officer Berlin, 12 May 2015 V1-6 Disclaimer Certain statements in this presentation contain formulations or terms referring to the future
More informationNew Treatment Options for Breast Cancer
New Treatment Options for Breast Cancer Brandon Vakiner, PharmD., BCOP Clinical Pharmacy Specialist - Oncology The University of Iowa Hospitals and Clinics Assistant Professor (Clinical) University of
More informationLung Cancer. Public Outcomes Report. Submitted by Omar A. Majid, MD
Public Outcomes Report Lung Cancer Submitted by Omar A. Majid, MD Lung cancer is the most common cancer-related cause of death among men and women. It has been estimated that there will be 226,1 new cases
More informationNews Release. Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma
Your Contacts News Release Merck KGaA, Darmstadt, Germany Media: Markus Talanow +49 6151 72 7144 Investor Relations +49 6151 72 3321 Pfizer Inc., New York, USA Media: Sally Beatty +1 212 733 6566 Investor
More informationHow To Treat Mesothelioma With A Tumor Stem Cell Inhibitor
FAK INHIBITOR DEFACTINIB (VS-6063) TARGETS MESOTHELIOMA CANCER STEM CELLS Rationale for maintenance therapy after conventional therapy Jonathan Pachter, Ph.D. Vice President of Research, Verastem, Inc.
More informationPHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec)
PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec) INDICATION IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable
More informationAdjuvant Therapy Non Small Cell Lung Cancer. Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015
Adjuvant Therapy Non Small Cell Lung Cancer Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015 No Disclosures Number of studies Studies Per Month 12 10 8 6 4 2 0 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3
More informationProtein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer
Protein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer Dan Vogl Lay Abstract Early stage non-small cell lung cancer can be cured
More informationRadiation Therapy in the Treatment of
Lung Cancer Radiation Therapy in the Treatment of Lung Cancer JMAJ 46(12): 537 541, 2003 Kazushige HAYAKAWA Professor and Chairman, Department of Radiology, Kitasato University School of Medicine Abstract:
More informationSummary ID# 13095. Clinical Study Summary: Study H3E-EW-B012
Page 1 Summary ID# 13095 Clinical Study Summary: Study H3E-EW-B012 First-line Treatment of Non-Small Cell Lung Cancer under Routine Conditions: Observational Study on Overall Survival Date summary electronically
More informationTreatment of Small Cell Lung Cancer: American Society of Clinical Oncology Endorsement of the American College of Chest Physicians (ACCP) Guideline
Treatment of Small Cell Lung Cancer: American Society of Clinical Oncology Endorsement of the American College of Chest Physicians (ACCP) Guideline An ASCO Endorsement of Treatment of Small Cell Lung Cancer:
More informationa Phase 2 prostate cancer clinical trial is ongoing. Table 2: Squalamine vs Standard-of-care literature
PRODUCT FACT SHEET Spring 2007 MISSION STATEMENT Genaera Corporation is a biopharmaceutical company with a focus on metabolic and respiratory diseases. The compounds in the Genaera pipeline address signal
More informationNCCN Non-Small Cell Lung Cancer V.1.2011 Update Meeting 07/09/10
Guideline Page and Request NSCL-3 Stage IA, margins positive delete the recommendation for chemoradiation. Stage IB, IIA, margins positive delete the recommendation for chemoradiation + Stage IIA, Stage
More informationHarmesh Naik, MD. Hope Cancer Clinic HOW DO I MANAGE STAGE 4 NSCLC IN 2012: STATE OF THE ART
Harmesh Naik, MD. Hope Cancer Clinic HOW DO I MANAGE STAGE 4 NSCLC IN 2012: STATE OF THE ART Goals Discuss treatment options for stage 4 lung cancer: New and old Discuss new developments in personalized
More informationLung Pathway Group Nintedanib (Vargatef) in advanced Non-Small Cell Lung Cancer (NSCLC)
Lung Pathway Group Nintedanib (Vargatef) in advanced Non-Small Cell Lung Cancer (NSCLC) Indication: In combination with docetaxel in locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma
More informationLung Pathway Group Pemetrexed and Cisplatin in Non-Small Cell Lung Cancer (NSCLC)
Indication: NICE TA181 First line treatment option in advanced or metastatic non-squamous NSCLC (histology confirmed as adenocarcinoma or large cell carcinoma) Performance status 0-1 Regimen details: Pemetrexed
More informationCytotoxic and Biotherapies Credentialing Programme Module 2
Cytotoxic and Biotherapies Credentialing Programme Module 2 1. The Cell Cycle 2. Cancer Therapies 3. Adjunctive Therapies On completion of this module the RN will State the difference between a normal
More informationtargeted therapy a guide for the patient
targeted therapy FOR LUNG CANCER a guide for the patient TABLE OF CONTENTS lung cancer basics... 2-3 Gene changes... 4-5 Testing... 7-8 Targeted therapy... 9-11 Drugs Targeting EGFR... 12 Drugs Targeting
More informationTeriflunomide is the active metabolite of Leflunomide, a drug employed since 1994 for the treatment of rheumatoid arthritis (Baselt, 2011).
Page 1 of 10 ANALYTE NAME AND STRUCTURE TERIFLUNOMIDE Teriflunomide TRADE NAME Aubagio CATEGORY Antimetabolite TEST CODE PURPOSE Therapeutic Drug Monitoring GENERAL RELEVANCY BACKGROUND sclerosis. The
More informationEarly Access to Medicines Scheme Treatment protocol Information for patients
Early Access to Medicines Scheme Treatment protocol Information for patients Introduction The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed
More informationTrials in Elderly Melanoma Patients (with a focus on immunotherapy)
Trials in Elderly Melanoma Patients (with a focus on immunotherapy) Where we were Immunotherapy Trials: past and present Relevance for real world practice Where we are SIOG October 2012 James Larkin FRCP
More informationLung cancer is not just one disease. There are two main types of lung cancer:
1. What is lung cancer? 2. How common is lung cancer? 3. What are the risk factors for lung cancer? 4. What are the signs and symptoms of lung cancer? 5. How is lung cancer diagnosed? 6. What are the available
More informationIs the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study
Turkish Journal of Cancer Volume 34, No.1, 2004 19 Is the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study MUSTAFA ÖZDO AN, MUSTAFA SAMUR, HAKAN BOZCUK, ERKAN ÇOBAN,
More informationThe TV Series. www.healthybodyhealthymind.com INFORMATION TELEVISION NETWORK
The TV Series www.healthybodyhealthymind.com Produced By: INFORMATION TELEVISION NETWORK ONE PARK PLACE 621 NW 53RD ST BOCA RATON, FL 33428 1-800-INFO-ITV www.itvisus.com 2005 Information Television Network.
More information