FDA approves Alimta for the treatment of non-small cell lung cancer

U.S. Food and Drug Administration has granted accelerated approval to pemetrexed for injection (Alimta, Eli Lilly and Company) on Aug 19, 2004. This drug is approved as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who has failed at least one type of prior chemotherapy. Efficiency and safety were were demonstrated in one multi-center, randomized trial conducted in 571 patients comparing single-agent Alimta versus docetaxel (Taxotere). Alimta, 500 mg/m2 intravenously, was administered over 10 minutes on day 1 of each 21-day cycle. Those patients who received Alimta also received dexamethasone for skin rash prophylaxis and vitamin B12 and folic acid supplementation. The primary efficacy endpoint of the study was survival, however Alimta failed to demonstrate superior survival compared to docetaxel. Non-inferiority for overall survival could not be demonstrated because there was only one small historical study with a total 104 patients from which to estimate docetaxel's survival effect. A meta-analysis of multiple historical studies is usually required to establish this survival effect estimation. In addition, comparison of the survival effect in this randomized trial was confounded by a 32% crossover rate of Alimta patients to docetaxel after tumor progression. The median survival time was 8.3 months for Alimta-treated patients and 7.9 months for docetaxel-treated patients. Secondary efficacy endpoints included response rate (Alimta 9.1%, docetaxel 8.8%), progression-free survival (Alimta and docetaxel, medians 2.9 months) and time-to progressive disease (Alimta, median 3.4 months; docetaxel, median 3.5 months).

Alimta has a more favorable safety profile compared to docetaxel. Alimta caused less neutropenia, febrile neutropenia, neutropenic infections and need for growth factors. Alimta causes less severe hair loss. Elevation of liver enzymes was more frequent with Alimta than docetaxel. Accelerated approval was based on the improved safety profile and effects on surrogate endpoints.

As a condition of accelerated approval, the applicant is required to conduct additional studies to demonstrate a clinical benefit, such as increased survival or improved disease-related symptoms.

Read more about Alimta here:
Pemetrexed is as good as docetaxel but with less side effects

Did you know?
U.S. Food and Drug Administration has granted accelerated approval to pemetrexed for injection (Alimta, Eli Lilly and Company) on Aug 19, 2004. This drug is approved as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who has failed at least one type of prior chemotherapy. Efficiency and safety were were demonstrated in one multi-center, randomized trial conducted in 571 patients comparing single-agent Alimta versus docetaxel (Taxotere)