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

On August 19, 2004, pemetrexed for injection (Alimta ® ; Eli Lilly and Company, Indianapolis, IN, http://www. lilly.com) received accelerated approval as monother- apy 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-eligi- ble patients were randomized to receive either peme- trexed or docetaxel (Taxotere ®