Summary of treatment benefits

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2 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 lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum based chemotherapy. Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non small cell lung cancer other than predominantly squamous cell histology. Malignant mesothelioma is a rare tumour affecting mesodermal tissue and whose origin has generally been linked to asbestos exposure. The incidence of malignant pleural mesothelioma has increased steadily since the 1950s. Pleural mesothelioma usually becomes clinically evident by symptoms such as dyspnea or chest pain from the pleura, chest wall, or mediastinum. At the time such symptoms occur, the disease is often locally advanced. The most common sites of origin are the pleura, accounting for 80% of cases, followed by peritoneum, pericardium, and tunica vaginalis testis. Survival of untreated patients is poor, with a median survival time ranging from 6 to 8 months, though the range may be much wider, depending on the characteristics and selection of the population of mesothelioma patients. Neither surgery nor radiotherapy generally results in increased survival. Randomized studies have shown that systemic combination therapy results in somewhat higher response rates than single agent therapy 1, 2. Lung cancer is one of the most common malignancies and continues to rise in incidence. One million new cases and over 900,000 lung cancer related deaths are reported each year worldwide. It is the leading cause of cancer death in men and the third leading cause in women. Almost 80% of lung cancers are classified as non small cell lung cancer (NSCLC), with 65% to 75% of cases presenting as locally advanced (stage III) or metastatic disease (stage IV). Inoperable patients diagnosed with stage III NSCLC generally receive chemotherapy as part of standard multimodality treatment. stage IIIb and IV patients typically receive chemotherapy alone as first line therapy. The median survival in first line therapy is approximately 7.9 months, with a 12 month median survival proportion of 33%. Approximately half of the patients treated with a first line combination regimen will receive single agent chemotherapy as second line treatment. Several chemotherapeutic agents were evaluated in phase 2 trials in the second line setting. Tumor response rates vary from study to study 3, 4, 5 VI.2.2 Summary of treatment benefits Pemetrexed is a new generation antifolate that inhibits multiple targets involved in folate metabolism. Antifolate drugs in the past have typically targeted and inhibited a single enzyme involved with folate metabolism. All living cells require folic acid and appropriate folate metabolism for cell growth. Specifically, folate metabolism is integral to purine, thymidine, and amino acid biosynthesis. Pemetrexed has been evaluated for its use in a variety of tumor types. It is currently approved for use in patients with malignant pleural mesothelioma and NSCLC. Pemetrexed has shown its utility as an effective drug for NSCLC. Analysis of its activity has revealed that patients with nonsquamous histologies benefit the most from the drug. Related to Malignant pleural mesothelioma, pemetrexed plus cisplatin confers a survival benefit of approximately 3 months compared with cisplatin alone. The combination treatment also appears to demonstrate advantages in terms of 1 year survival, median time to progressive disease, tumor response rate and quality of life. Pemetrexed plus cisplatin appears to offer greater survival benefits than cisplatin alone in patients with advanced disease. VI.2.3 Unknowns relating to treatment benefits There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 ml/min; therefore the use of pemetrexed is not recommended. No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified. However, patients with hepatic impairment such as bilirubin > 1.5 times the upper limit of normal and/or aminotransferase > 3.0 times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present) have not been specifically studied. RMP_Pemetrexed_v02 Page 85 of 155

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9 Risk Management Plan PEMETREXED Powder for concentrate for Solution for infusion ischaemia) SOC: Ear and labyrinth disorders (Hearing loss, Hypoacusis) 3. The routine risk minimisation measures in the RMP were updated as necessary to reflect the changes made to the list of safety concerns. 4. The reference safety documents have been updated. RMP_Pemetrexed_v02 Page 92 of 155

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