Global Development Projects
|
|
- Lucy Tamsin O’Neal’
- 7 years ago
- Views:
Transcription
1
2 Global Development Projects 1/9 Development code ONO-4641 Target Disease Overseas* Japan* Renal cell carcinoma, Melanoma, Non-small cell lung cancer etc Multiple sclerosis III (BMS) 海外 ( 欧米 ) で 2 化合物以上の上市 ( 導出 ) 現在のグローバル開発品状況一覧表 III III under preparation (with Merck KGaA) ONO-6950 Bronchial asthma II I ONO-4053 Allergic rhinitis II - ONO-2952 Irritable bowel syndrome (IBS) II - ONO-9054 Glaucoma, ocular hypertension I - ONO-7746 Thrombocytopenia I - ONO-4059 B-cell lymphoma I - ONO-8055 Underactive bladder I - ONO-8539 Gastroesophageal reflux disease I *the most advanced stage is shown ONO-2160 Parkinson s disease - I
3 Product name/product candidate name/development code Planned indication Japan ONO-4164SC (Orencia SC) Development pipeline list (Japan) 2/9 Rheumatoid arthritis 国内で 10 品以上の上市 現在の国内開発品状況一覧表 P a s s e d E v a l u a t i o n C o m m i t t e e Glactiv 12.5mg Tablets (additional formulation) Type II diabetes with severe renal dysfunction F i l i n g Onoact (additional indication) Tachyarrhythmia in low cardiac function F i l i n g Glactiv (additional indication) Type 2 diabetes (combination therapy with rapid-acting SU) III Glactiv (FDC with Metformin) Type 2 diabetes III Proemend (pediatric) Chemotherapy-induced nausea and vomiting III Rivastach Patch (Additional dosing regimen) Alzheimer s disease III Renal cell carcinoma III ONO-2745 General anetsthesia II / III ONO-7165 (Stimuvax) Non-small cell lung cancer II ONO-4641 Multiple sclerosis (International study including Japan) II ONO-3849 Opioid-induced constipation II ONO-7643 Cancer cachexia II Melanoma II Non-small cell lung cancer II ONO-2745 ICU sedation II ONO-5163 Secondary hyperparathyroidism I / II ONO-7057 Multiple myeloma I / II ONO-6950 Bronchial asthma I ONO-7056 Pancreatic cancer I ONO-7628 MX1 Hepatic cell carcinoma I ONO-1162 Chronic heart failure I ONO-2160 Parkinson s disease I
4 Product Name/Development code Target disease Overseas Japan ONO-7057 (Carfilzomib) ONO-3849 Cancer/Cancer-related projects 3/9 Multiple myeloma Opioid-induced constipation Launched in US (Onyx) Launched (Progenics) Renal cell carcinoma III (JP/US/EU, with BMS) Melanoma III (BMS ) II Non-small cell lung cancer III (BMS ) II ONO-7165 (Stimuvax) Non-small cell lung cancer III (Merck KGaA) II ONO-7643 Cancer cachexia III (Helsinn) II Proemend (pediatrics) Chemotherapy-induced nausea and vomiting II (Merck) III I/II II Hematologic malignancies B cell lymphoma, T cell lymphoma, Multiple myeloma, Hodgkin lymphoma, Chronic leukemia I (BMS) hepatocellular carcinoma I (BMS) ONO-7746 Chemotherapy-induced thrombocytopenia I - ONO-7056 (Salirasib) Pancreatic cancer etc I (Kadmon) I ONO-7268MX1 Hepatic cell carcinoma etc - I ONO-7058 (ONX0912) Cancer I (Onyx) - ONO-4059 B cell lymphoma I -
5 Development status of (nivolumab) 4/9 Development code Target disease Overseas Japan Renal cell carcinoma III (JP/US/EU, with BMS) Melanoma III (BMS) II Non-small cell lung cancer III (BMS) II hematologic malignancies B cell lymphoma, T cell lymphoma, Multiple myeloma, Hodgkin lymphoma, Chronic leukemia I (BMS) hepatocellular carcinoma I (BMS) Melanoma ( combination with Ipilimumab ) Non-small cell lung cancer ( combination with chemotherapy ) Renal cell carcinoma ( combination with sunitinib, pazopanib, or ipilimumab ) I (BMS) I (BMS) I (BMS) I
6 Outline : Drug Therapy Flow Chart for Non-Small Cell Lung Cancer Patients naïve to chemotherapy Approx % Approx % Non-Squamous cell cancer Squamous cell cancer Approx % Approx % EGFR gene mutation positive EGFR gene mutation negative/unknown 5/9 1 st line EGFR-TKI Combination with platinum-doublet 2 nd line 3 rd line Combination with platinum-doublet EGFR-TKI Decetaxel, gemcitabine, pemetrexed etc Decetaxel, gemcitabine, pemetrexed etc : Population aimed to obtain the indication for (monotherapy) this time : Population aimed to obtain the indication for (combination or monotherapy) in the future EGFR : Epidermal Growth Factor Receptor, TKI: Tyrosine Kinase Inhibitor * ALK inhibitors are recommended for ALK-rearranged non-small cell lung cancer
7 Treatment Flow for Renal Cell Carcinoma in Japan 6/9 Advanced or metastatic renal cell carcinoma ( low or middle risk) Lung metastasis only Tyrosine kinase inhibitor (snitinib, sorafenib) IFN-α Tyrosine kinase inhibitor (snitinib, sorafenib) mtor inhibitor (everolimus) Clinical study etc : Population aimed to obtain the indication for (monotherapy) this time : Population aimed to obtain the indication for (combination or monotherapy) in the future * axitinib is not reflected in Japanese guideline 2011 yet.
8 American Society of Clinical Oncology (ASCO) 2013/5/31~6/4, Chicago ( Interim Analysis in Clinical Trials ) 7/9 Non-small cell lung cancer (NSCLC) Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS ; ) in patients (pts) with previously treated advanced nonsmall cell lung cancer (NSCLC). A phase I study of nivolumab (anti-pd-1; BMS , ) plus platinumbased doublet chemotherapy (PTdoublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts). Renal cell carcinoma (mrcc) Survival, safety, and response duration results of nivolumab (Anti-PD-1; BMS ; ) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mrcc): Long-term patient follow-up. Melanoma Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase I trial of nivolumab (anti-pd-1; BMS ; ). Safety and clinical activity of nivolumab (anti-pd-1, BMS , ) in combination with ipilimumab in patients (pts) with advanced melanoma (MEL). Peripheral and tumor immune correlates in patients with advanced melanoma treated with combination nivolumab (anti-pd-1, BMS , ) and ipilimumab. Phase I/II trial of PD-1 antibody nivolumab with peptide vaccine in patients naive to or that failed ipilimumab. Safety and efficacy of adjuvant anti-pd1 therapy (nivolumab) in combination with vaccine in resected high-risk metastatic melanoma. Other Association of tumor PD-L1 expression and immune biomarkers with clinical activity in patients (pts) with advanced solid tumors treated with nivolumab (anti-pd-1; BMS ; ). Nivolumab (anti-pd-1; BMS ; ) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.
9 American Society of Clinical Oncology (ASCO) 2013/5/31~6/4, Chicago ( Study design 1 ) 8/9 Non-small cell lung cancer (NSCLC) A phase III comparative study of nivolumab (anti-pd-1; BMS ; ) versus docetaxel in patients (pts) with previously treated advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC). A phase III comparative study of nivolumab (anti-pd-1; BMS ; ) versus docetaxel in patients with previously treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC). Renal cell carcinoma (mrcc) A phase III comparative study of nivolumab (anti-pd-1; BMS ; ) versus everolimus in patients (pts) with advanced or metastatic renal cell carcinoma (mrcc) previously treated with antiangiogenic therapy. A phase I study of nivolumab (anti-pd-1; BMS ; ) in combination with sunitinib, pazopanib, or ipilimumab in patients (pts) with metastatic renal cell carcinoma (mrcc). Melanoma A phase III open-label study of nivolumab (anti-pd-1; BMS ; ) versus investigator s choice in advanced melanoma patients progressing post anti-ctla-4 therapy. A phase III, randomized, double-blind study of nivolumab (anti-pd-1; BMS ; ) versus dacarbazine in patients (pts) with previously untreated, unresectable, or metastatic melanoma (MEL). An open-label, randomized, phase II study of nivolumab (anti-pd-1; BMS ; ) given sequentially with ipilimumab in patients (pts) with advanced or metastatic melanoma (MEL). An exploratory study of the biologic effects of nivolumab (Anti-PD-1; BMS ; ) treatment in patients (pts) with advanced (unresectable or metastatic) melanoma (MEL).
10 American Society of Clinical Oncology (ASCO) 2013/5/31~6/4, Chicago ( Study design 2 ) 9/9 Other A phase I dose-escalation study evaluating the effects of nivolumab (anti-pd-1; BMS ; ) in patients (pts) with select relapsed or refractory hematologic malignancies. Phase I dose escalation study of recombinant interleukin-21 (ril-21; BMS ) in combination with nivolumab (anti- PD-1; BMS ; ) in patients (pts) with advanced or metastatic solid tumors. A phase I dose-escalation and cohort expansion study of lirilumab (anti-kir; BMS ) administered in combination with nivolumab (anti-pd-1; BMS ; ) in patients (Pts) with advanced refractory solid tumors. Phase I dose escalation study of nivolumab (Anti-PD-1; BMS ; ) in patients (pts) with advanced hepatocellular carcinoma (HCC) with or without chronic viral hepatitis.
ONO PHARMACEUTICAL CO., LTD.
ONO PHARMACEUTICAL CO., LTD. February 4, 2013 Ono Pharmaceutical Co., Ltd. has announced its consolidated financial results for nine months ended December 31,. This First - Third Quarter Flash Report 2013
More informationCheckMate -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 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 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 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 informationInspira (Vineland/Woobury) Open Clinical Trials as of December 16, 2015
Inspira (Vineland/Woobury) Open Clinical Trials as of December 16, 2015 Advanced Refractory Solid Tumors or Lymphomas ECOG-ACRIN EAY131 (NCI CIRB) Targeted Therapy Directed by Genetic Testing in Treating
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 informationCLINICAL POLICY Department: Medical Management Document Name: Opdivo Reference Number: CP.PHAR.121 Effective Date: 07/15
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
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 informationMOH Policy for dispensing NEOPLASTIC DISEASES DRUGS
MOH Policy for dispensing NEOPLASTIC DISEASES DRUGS All prescriptions for antineoplastic drugs must be accompanied by the MOH special form. All the attachments mentioned on this form shall be submitted
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 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 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 informationALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials)
ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials) 3 Integrated Trials Testing Targeted Therapy in Early Stage Lung Cancer Part of NCI s Precision Medicine Effort in
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 informationIMMUNOMEDICS, INC. February 2016. Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases February 2016 Forward-Looking Statements This presentation, in addition to historical information, contains certain
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 informationWhat is the Optimal Front-Line Treatment for mrcc? Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center
What is the Optimal Front-Line Treatment for mrcc? Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center The Case for Immunotherapy in mrcc 1. Achieves patient s goal 2.
More information2014-06-10 Approved Bendamustine - Treatment of relapsed low grade NHL in patients unable to receive standard therapy 2014-05-
Sub. Sub. Status -06-16 Approved Lenalidomide - 2nd line treatment of multiple myeloma in patients who have contraindications to the use of bortezomib -06-16 Approved Lenalidomide - 2nd line treatment
More informationSYSTEMIC THERAPY FOR STAGE IV NON-SMALL CELL LUNG CANCER: AMERICAN SOCIETY OF CLINICAL ONCOLOGY CLINICAL PRACTICE GUIDELINE UPDATE
Which patients with stage IV NSCLC should be treated with chemotherapy? NSCLC with nonsquamous cell carcinoma, negative or unknown EGFR-sensitizing mutation and ALK gene rearrangement status, and PS 0-1
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 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 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 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 informationWhat is New in Oncology. Michael J Messino, MD Cancer Care of WNC An affiliate of Mission hospitals
What is New in Oncology Michael J Messino, MD Cancer Care of WNC An affiliate of Mission hospitals Personalized Medicine Personalized Genomics Genomic Medicine Precision Medicine Definition Application
More informationImmuno-Oncology 2015: A New Landscape in Lung Cancer
Immuno-Oncology 2015: A New Landscape in Lung Cancer David R. Spigel, M.D. Lung Cancer Program Director Sarah Cannon Research Institute/Tennessee Oncology, PLLC Nashville, TN Off-Label Use Disclosure(s)
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 informationChapter 7: Lung Cancer
Chapter 7: Lung Cancer Contents Chapter 7: Lung Cancer... 1 Small Cell... 2 Good PS + Limited stage... 2 Cisplatin/etoposide... 2 Concurrent chemotherapy + XRT... 2 Good / Intermediate PS... 2 Carboplatin
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 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 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 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 informationAnticancer Immunotherapy A New Weapon Against Cancer JON STEPHENS, MPHIL SENIOR ANALYST, ONCOLOGY
Anticancer Immunotherapy A New Weapon Against Cancer JON STEPHENS, MPHIL SENIOR ANALYST, ONCOLOGY A robust new approach Since its inception in the mid-0th century, chemotherapy has been the mainstay of
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 informationCorporate Presentation June 2, 2015
Corporate Presentation June 2, 2015 SAFE HARBOR STATEMENT This presentation contains forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these
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 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 informationImmunotherapy for Metastatic Renal Cell Carcinoma
Immunotherapy for Metastatic Renal Cell Carcinoma Timothy M. Kuzel, MD Professor of Medicine and Dermatology Feinberg School of Medicine Northwestern University Chicago, Ilinois ICLIO 1 st Annual National
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 informationMedication Policy Manual. Topic: Alimta, pemetrexed Date of Origin: May 12, 2010
Medication Policy Manual Policy No: dru213 Topic: Alimta, pemetrexed Date of Origin: May 12, 2010 Committee Approval Date: February 17, 2015 Next Review Date: February 2016 Effective Date: March 1, 2015
More informationProposal for Tyrosine Kinase Inhibitors for Non Small Cell Lung Cancer
31 May 2012 Proposal for Tyrosine Kinase Inhibitors for Non Small Cell Lung Cancer PHARMAC is seeking feedback on a proposal to: fund gefitinib (Iressa) as a first line treatment for patients with locally
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 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 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 informationREPORT ASCO 2011 CHICAG0 : RESPIRATORY ONCOLOGY Johan Vansteenkiste / Christophe Dooms, Univ. Hospital Leuven and Leuven Lung Cancer Group
1 REPORT ASCO 2011 CHICAG0 : RESPIRATORY ONCOLOGY Johan Vansteenkiste / Christophe Dooms, Univ. Hospital Leuven and Leuven Lung Cancer Group 10 MESSAGE HIGHLIGHTS Early stage non-small cell lung cancer
More informationCo-pay assistance organizations offering assistance
Acromegaly Acute Exacerbations of Multiple Sclerosis Acute Porphyrias Advanced Idiopathic Parkinson' s Disease Age-Related Macular Degeneration www.theassistancefund.org Alcohol Dependence Alpha-1 Antitrypsin
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 informationBreast Clinical Trials ADJUVANT, HER2+ BRE- 186 (Cohort A & B closed) Phase II Therapeutic Eribulin provided
FOR MORE ABOUT OR TO REFER A PATIENT TO ANY OF OUR CLINICAL TRIALS, PLEASE CONTACT THE OHC RESEARCH DEPARTMENT AT 1.800.710.4678. Breast Clinical Trials ADJUVANT, HER2+ BRE- 186 (Cohort A & B closed) Eribulin
More informationStudy EudraCT Nr. Phase Function Period
1 Investigators Study Experience Name: Function: Site: Dr. Mathias Hoiczyk Investigator Universitätsklinikum Essen Westdeutsches Tumorzentrum Innere Klinik (Tumorforschung) Hufelandstr. 55 45122 Essen
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 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 informationPfizer Forms Global Alliance with Merck KGaA, Darmstadt, Germany to Accelerate Presence in Immuno-Oncology. November 17, 2014
Pfizer Forms Global Alliance with Merck KGaA, Darmstadt, Germany to Accelerate Presence in Immuno-Oncology November 17, 2014 Forward-looking statements Our discussions during this conference call will
More informationDecision to Continue the Development of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer to be Announced
September 27, 2013 ONO PHARMACEUTICAL CO., LTD. Corporate Communications Phone: +81-6-6263-5670 Decision to Continue the Development of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer to be Announced
More informationNational Clinical Trials Network Groups Update Fall 2014
National Clinical Trials Network Groups Update Fall 2014 Walter J Curran, Jr, MD An NRG Oncology Group Chair Executive Director Winship Cancer Institute of Emory University Atlanta, GA NCTN Groups Update
More informationMoving forward, where are we with Clinical Trials?
Moving forward, where are we with Clinical Trials? Dennis A. Wigle Division of Thoracic Surgery Mayo Clinic AATS/STS General Thoracic Surgery Symposium Sunday, April 27 th 2014 2012 MFMER slide-1 Where
More informationBiomarker Trends in Breast Cancer Research
WHITE PAPER Biomarker Trends in Breast Cancer Research Jason Hill, PhD, Associate Director, External Science Affairs, Quintiles Quintiles examines the novel drug combinations and mechanisms of action that
More informationPublic-Private Partnerships in early phase clinical research: Spurring access to innovative therapeutics
EPAAC WP8 Research Forum - 2 July, Sofitel Hotel Europe, Brussels Public-Private Partnerships in early phase clinical research: Spurring access to innovative therapeutics JY Blay, Past President EORTC
More informationClinical Trials Currently Open At Genesis Health System
A Multicenter, Randonmized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SUN13837 Injection in Adult Subjects with Acute Spinal Cord Injury.
More informationThe New Kid on the Block for Advanced Renal Cell Carcinoma
The New Kid on the Block for Advanced Renal Cell Carcinoma Wyeth Pharmaceuticals recently launched Torisel (temsirolimus), a targeted, first-in-class mtor inhibitor. This new treatment for metastatic renal
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 informationFuture Oncology: Technology, Products, Market and Service Opportunities
Brochure More information from http://www.researchandmarkets.com/reports/296370/ Future Oncology: Technology, Products, Market and Service Opportunities Description: Future Oncology is an analytical newsletter
More informationSuccesses and Limitations of Targeted Cancer Therapy in Lung Cancer
Successes and Limitations of Targeted Cancer Therapy in Lung Cancer Kenichi Suda a, b Tetsuya Mitsudomi a a Division of Thoracic Surgery, Department of Surgery, Kinki University Faculty of Medicine, Osaka-Sayama,
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 informationPROSPETTIVE FUTURE NEL TRATTAMENTO. Cinzia Ortega Dipartimento di Oncologia Medica Fondazione del Piemonte per l Oncologia I.R.C.C.S.
PROSPETTIVE FUTURE NEL TRATTAMENTO MEDICO DEL mrcc Cinzia Ortega Dipartimento di Oncologia Medica Fondazione del Piemonte per l Oncologia I.R.C.C.S. Candiolo Future strategies in mrcc Improve therapeutic
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 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 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 informationCancerTREATMENT NGS+ NSCLC Summary Report Page 1 of 7 PATIENT SPECIMEN PHYSICIAN
Page 1 of 7 POSITIVE TEST RESULTS Biomarker Result DETECTED NEGATIVE TEST RESULTS FDA Approved Therapies Targeting Molecular Pathway TEST DESCRIPTION: CancerTREATMENT NGS+ uses Next Generation Sequencing
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 informationBNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED
ASX ANNOUNCEMENT 3 August 2011 ABN 53 075 582 740 BNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED Data from renal cancer trial supports progression of the trial: o Combination
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 informationGENETIC PROFILES AND TARGETED TREATMENT OF CANCER - PERSONALIZED MEDICINE
GENETIC PROFILES AND TARGETED TREATMENT OF CANCER - PERSONALIZED MEDICINE Branko Zakotnik MD, PhD Department of Medical Oncology Institute of Oncology Ljubljana 1 I have no conflict of interest to declare
More informationBOLT Hem/Onc Thought Leader Panel #38 Cancer Immunotherapy 2014-05
Syndicated Thought Leader Insight Healthcare & Pharmaceutical Research Cancer Immunotherapy Melanoma, Non- Small Cell Lung Cancer, Renal Cell Carcinoma Thought Leader Panel #38 2014-05 Therapeutic Area:
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 informationImmune Therapy for Pancreatic Cancer
Immune Therapy for Pancreatic Cancer December 16, 2014 If you experience technical difficulty during the presentation: Contact WebEx Technical Support directly at: US Toll Free: 1-866-229-3239 Toll Only:
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 informationNon-Small Cell Lung Cancer
Non-Small Cell Lung Cancer in East tasia Chia-Chi (Josh) Lin, MD, PhD 林 家 齊 Director of Phase I Center, e Department of Oncology, National Taiwan University Hospital Clinical Associate Professor, Department
More informationFuture Directions in Clinical Research. Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center
Future Directions in Clinical Research Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center Outline 1. Status of Cancer Treatment 2. Overview of Clinical Research at UCDCC 3.
More informationStudy on Melanoma - New Research for Cancer Patients
A service of the U.S. National Institutes of Health Trial record 7 of 203 for: Melanoma Analysis Previous Study Return to List Next Study Expression Analysis of Specific Markers in Non-small Cell Lung
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 informationPulmonary and Critical Care Regional Symposium April 25, 2015
Pulmonary and Critical Care Regional Symposium April 25, 2015 2015: Molecular Medicine, Resistance Mutations and Immunotherapy. Keeping Up With The Latest in NSCLC Barbara J. Gitlitz MD Associate Professor
More informationREFERENCE CODE GDHC256CFR PUBLICAT ION DATE SEPTEMBER 2014 HER2-POSITIVE BREAST CANCER CHINA DRUG FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC256CFR PUBLICAT ION DATE SEPTEMBER 2014 HER2-POSITIVE BREAST CANCER CHINA DRUG FORECAST AND MARKET ANALYSIS TO 2023 Executive Summary Sales for HER2-Positive Breast Cancer in China Market
More informationClinical Management Guideline Management of locally advanced or recurrent Renal cell carcinoma. Protocol for Planning and Treatment
Protocol for Planning and Treatment The process to be followed in the management of: LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA Patient information given at each stage following agreed information
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 informationShifting the Paradigm for Maintenance Therapy for Non small-cell Lung Cancer
J Hong Kong Col Radiol. 2010;13(Suppl):S16-21 ORIGINAL ARTICLE Shifting the Paradigm for Maintenance Therapy for Non small-cell Lung Cancer VHF Lee Department of Clinical Oncology, Queen Mary Hospital,
More informationSmall cell Lung cancer New Chemotherapy options. Nicolas Mach, MD,PD
Small cell Lung cancer New Chemotherapy options Nicolas Mach, MD,PD > 40 negative Phase III trials List of unsucessful drugs Pemetrexed, imatinib, bevacizumab, bcl-2 antagonist, ASCT, CASE PRESENTATION
More informationREPORT PERSPECTIVES IN LUNG CANCER 2010 AMSTERDAM
REPORT PERSPECTIVES IN LUNG CANCER 2010 AMSTERDAM Valerie Van Damme, Isabelle Wauters, Johan Vansteenkiste Univ. Hospital Leuven and Leuven Lung Cancer Group Introduction Perspectives in Lung Cancer (PILC)
More informationThe Value of Innovation in Oncology: Recognizing Emerging Benefits Over Time
WHITE PAPER MAY 2015 The Value of Innovation in Oncology: Recognizing Emerging Benefits Over Time Nicole Sweeney and Thomas F. Goss, PharmD Boston Healthcare Associates, Inc., Boston, Berlin, Shanghai
More informationNavigating GIST. The Life Raft Group June 12, 2008
Navigating GIST Clinical Trials The Life Raft Group June 12, 2008 Some observations: Annually, only 3% of adult patients participate in cancer clinical trials. Lara et. al; Evaluation of factors affecting
More informationTargeterbare mutationer / biomarkører Status og udfordringer for patologien
Targeterbare mutationer / biomarkører Status og udfordringer for patologien Birgit Guldhammer Skov overlæge, dr.med. Patologi afdelingen Rigshospitalet Biomarkers lung cancer Last 3-5 years More and more
More informationCancer Immunotherapy: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies - Overview
Brochure More information from http://www.researchandmarkets.com/reports/3066973/ Cancer Immunotherapy: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies - Overview Description:
More informationPharmacogenomic markers in EGFR-targeted therapy of lung cancer
Pharmacogenomic markers in EGFR-targeted therapy of lung cancer Rafal Dziadziuszko, MD, PhD University of Colorado Cancer Center, Aurora, CO, USA Medical University of Gdansk, Poland EMEA Workshop on Biomarkers,
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 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 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 informationThird-line or fourth-line chemotherapy in non-small-cell lung cancer patients with relatively good performance status
Available online at www.sciencedirect.com Journal of the Chinese Medical Association 74 (2011) 209e214 Original Article Third-line or fourth-line chemotherapy in non-small-cell lung cancer patients with
More informationEndpoint Selection in Phase II Oncology trials
Endpoint Selection in Phase II Oncology trials Anastasia Ivanova Department of Biostatistics UNC at Chapel Hill aivanova@bios.unc.edu Primary endpoints in Phase II trials Recently looked at journal articles
More informationTable of Contents. Data Supplement 1: Summary of ASTRO Guideline Statements. Data Supplement 2: Definition of Terms
Definitive and Adjuvant Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation
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 informationStage I, II Non Small Cell Lung Cancer
Stage I, II Non Small Cell Lung Cancer Best Results T1 (less 3 cm) N0 80% 5 year survival No Role Adjuvant Chemotherapy Radiation Therapy Reduces Local Recurrence No Improvement in Survival 1 Staging Mediastinal
More information