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U.S. FDA approves Novartis lung cancer drug
April 29, 2014 / 8:10 PM / in 4 years

U.S. FDA approves Novartis lung cancer drug

April 29 (Reuters) - U.S. health regulators on Monday approved a drug for advanced lung cancer developed by Swiss drugmaker Novartis AG that is intended to treat patients with a specific genetic mutation.

The drug, ceritinib, from a new class medicines known as ALK inhibitors, was approved four months ahead of the expected Food and Drug Administration decision date.

It will be sold under the brand name Zykadia, the FDA and Novartis said.

Zykadia was approved for use in non-small cell lung cancer patients who had previously been treated with Pfizer Inc’s Xalkori, another ALK inhibitor.

About four percent of non-small cell lung cancer patients have the specific mutation of the ALK (anaplastic lymphoma kinase) protein for which the drug is targeted. They are often non smokers.

“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,” Richard Pazdur, director of cancer products in FDA’s Center for Drug Evaluation and Research, said in a statement.

It had received the FDA’s new breakthrough designation, intended to speed up the review of medicines seen as an advance over existing therapies or filling a serious unmet need. (Reporting by Bill Berkrot; Editing by Bernard Orr)

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