Novartis gains US approval for NSCLC drug candidate Zykadia

The US Food and Drug Administration said late yesterday that it has granted accelerated approval for Swiss drug major Novartis’ (NOVN: VX) Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

“Today’s approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It also demonstrates the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review,” he added.

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