FDA Panel Advises Rejecting Broader Indication for OSI’s Tarceva

An FDA advisory panel has voted 12–1 to recommend the agency reject expanded use of OSI Pharmaceuticals’ Tarceva as first-line maintenance treatment for patients with stable nonsmall cell lung cancer after agency staff raised concerns about the drug’s benefit. The Oncologic Drugs Advisory Committee found that OSI didn’t demonstrate that Tarceva (erlotinib) had a clear benefit as a maintenance therapy. “There’s a lot of doubt about what the real impact is,” Brent Logan, a panel member and associate professor of biostatistics at the Medical College of Wisconsin, said Wednesday.
Drug Industry Daily