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The FDA has approved erlotinib (Tarceva,™ OSI/Genentech) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) for patients whose disease progressed despite at least one chemotherapy regimen.
The tablet, taken daily, blocks signals that stimulate growth in cancer cells by inhibiting an enzyme associated with epidermal growth factor receptor.
The FDA based its approval on a randomized phase 3 pivotal trial in which treated patients survived for a median of 6.7 months and placebo patients survived 4.7 months. After one year, 31.2% of the treated patients were alive, compared with 21.5% of the placebo patients.
