New York's OSI Pharmaceuticals has had a supplemental New Drug Application (NDA) for the use of Tarceva (erlotinib) for non-small cell lung cancer accepted by the US Food and Drug Administration (FDA).
The drug will be used 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.
OSI CEO Colin Goddard said he was happy over the decision.
"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," Goddard said.
The NDA filing was based on the results of a pivotal Phase III placebo-controlled, randomised, double-blind trial known as Saturn.