FDA extend approval of Alimta (Eli Lilly) for maintenance treatment in NSCLC

The FDA has announced that patients may receive Alimta (pemetrexed for injection), from Eli Lilly, as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients. Alimta is indicated for the maintenance treatment of patients with locally advanced or metastatic NS NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Alimta is not indicated for patients with squamous-cell NSCLC. Myelosuppression is usually the dose-limiting toxicity with Alimta therapy.

FDA and European Commission approvals were based on results from PARAMOUNT, a Phase III trial, the final results of which were shared at the American Society of Clinical Oncology meeting in June 2012. PARAMOUNT was the first study to evaluate the first-line use of Alimta plus cisplatin therapy followed immediately by the use of Alimta as a single-agent in the continuation maintenance setting.