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Regulatory Issues

FDA Drug Approval Summary: Pemetrexed for Injection (Alimta^®) for the Treatment of Non-Small Cell Lung Cancer

Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, USA

Correspondence: Correspondence: Martin H. Cohen, M.D., Food and Drug Administration, HFD-150 5600 Fishers Lane, Rockville, Maryland 20857, USA. Fax: 301-594-0499; e-mail: cohenma{at}cder.fda.gov

ABSTRACT

On August 19, 2004, pemetrexed for injection (Alimta^®; Eli Lilly and Company, Indianapolis, IN, http://www.lilly.com) received accelerated approval as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had received prior chemotherapy.

Approval was primarily based on a single, controlled, unblinded trial. Five hundred seventy-one protocol-eligible patients were randomized to receive either pemetrexed or docetaxel (Taxotere^®; Aventis Pharmaceuticals Inc., Bridgewater, NJ, http://www.aventispharmaus.com). The primary efficacy end point was overall survival. The median survival times were 8.3 months in the pemetrexed arm and 7.9 months in the docetaxel arm. Neither superiority nor noninferiority for overall survival could be demonstrated, the latter because a reliable and consistent survival effect of docetaxel could not be estimated and because of significant crossover of pemetrexed-treated patients to docetaxel after tumor progression. Comparable response rates, 9.1% for pemetrexed and 8.8% for docetaxel, times to progressive disease, and progression-free survival times supported the conclusion that an effect of pemetrexed on survival was reasonably likely, however.

In addition, pemetrexed was felt to have a more favorable safety profile than docetaxel. Of greatest importance, pemetrexed caused significantly less neutropenia, febrile neutropenia, neutropenic infections, and need for granulocyte/macrophage colony-stimulating factors.

Key Words. Pemetrexed for injection • Alimta^® • Non-small cell lung cancer, metastatic • Second-line treatment

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