OSI Pharmaceuticals Receives Acceptance Of Tarceva Supplemental NDA By FDA

Headquartered in Yew York, OSI Pharmaceuticals has announced that the FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva (erlotinib) as a first-line maintenance treatment for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy.

The NDA filing is based on a pivotal phase III placebo-controlled, randomized, double-blind trial known as Saturn.

Colin Goddard, CEO of OSI, said: We are pleased with the FDA’s decision to review the data to evaluate Tarceva as a first-line maintenance therapy.

This decision puts us one step closer toward accomplishing our goal of making Tarceva available earlier in the course of lung cancer treatment, offering a non-chemotherapy choice for all NSCLC patients in the maintenance setting, he added.