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.