Roche and OSI Pharmaceuticals Gain Approval for Cancer Treatment

Roche and OSI Pharmaceuticals have gained US Food and Drug Administration (FDA) approval for the use of Tarceva as a maintenance treatment for non-small cell lung cancer.

The FDA's decision comes despite an earlier negative opinion from its advisory panel which voted 12-1 against recommending approval for the drug’s expanded use. The drug will now have to compete with Alimta in the maintenance setting.

Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche/Chugai) is already approved by the FDA and EMA (European Medicines Agency) for the second- and third-line treatment of advanced Non-Small Cell Lung Cancer (NSCLC). This approval means that the drug will be available as a maintenance therapy for patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, for both squamous and non-squamous histologies.