FDA Weighs Erlotinib as Maintenance Therapy in NSCLC

December 17, 2009

An FDA-convened panel of outside experts recommended 12 to 1 against approving approval erlotinib (Tarceva) as an early maintenance therapy for patients with non–small cell lung cancer (NSCLC).

An FDA-convened panel of outside experts recommended 12 to 1 against approving erlotinib (Tarceva) as an early maintenance therapy for patients with non—small cell lung cancer (NSCLC). In a statement posted at the FDA Website last week, the agency’s own reviewers noted that erlotinib, manufactured by OSI Pharmaceuticals, slows lung cancer progression and prolongs survival when used after chemotherapy but expressed concerns about whether approval was warranted for this indication.

The FDA’s review included data from a study of 889 patients who started erlotinib or placebo immediately after chemotherapy. The erlotinib group experienced stable disease for at least 3 months, but this was only a 1-month improvement compared with the placebo arm. The FDA had also suggested approval might not be indicated because patients have “other available treatment options,” including pemetrexed (Alimta), which was approved earlier this year as maintenance therapy for NSCLC; and docetaxel (Taxotere), which has been shown to improve survival in lung cancer by 3 months when treatment is initiated after signs of progression following stable disease on chemotherapy. The FDA also pointed out that erlotinib was less effective in patients with EGFR-negative tumors and those with squamous histology.

An earlier trial of erlotinib had investigated treating patients with NSCLC who had achieved stable disease on chemotherapy with erlotinib after evidence of progression. These patients experienced longer mean overall survival than those treated with immediate erlotinib. This factored into the panel’s decision, although panelists cited the “modest” overall survival benefit associated with early administration of erlotinib as the primary reason for recommending against its approval. Although the FDA is not bound by the panel’s recommendations, it generally follows the panel’s advice.