SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration has extended its review period for a lung cancer drug made by Genentech and OSI Pharmaceuticals, the two companies announced.
OSI submitted additional study data to support the companies’ regulatory approval application for Tarceva (erlotinib) as a first-line maintenance therapy for advanced non-small cell lung cancer, prompting the FDA to extend its review period by 90 days. The agency would have decided on whether to approve the drug on Monday, but will take until April.
Tarceva already has approval as a monotherapy in patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed after up to two courses of chemotherapy and as a treatment for pancreatic cancer, in combination with gemcitabine chemotherapy.