FDA grants accelerated approval to Zykadia

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday granted approval to Zykadia (ceritinib) for patients with a specific type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

The drug — an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor — blocks proteins that promote the development of cancerous cells and is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib.

"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, M.D., 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 and approval, reflecting the promise of the breakthrough therapy designation program.”

Zykadia is marketed by Novartis, which is based in East Hanover, N.J.


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