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U.S. FDA approves Gilead's blood cancer drug Zydelig
July 23, 2014 / 4:05 PM / 3 years ago

U.S. FDA approves Gilead's blood cancer drug Zydelig

July 23 (Reuters) - The U.S. Food and Drug Administration has approved Gilead Inc’s drug Zydelig to treat three types of blood cancer, the agency said on Wednesday.

The FDA approved it for use in combination with Roche AG’s Rituxan for patients with relapsed chronic lymphocytic leukemia.

The agency gave the drug so-called accelerated approval for patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma who have received at least two prior therapies.

Under the accelerated approval program, companies must conduct additional trials to confirm that the drug’s apparent benefit is real.

The drug will carry a boxed warning highlighting the risk of serious and potentially fatal toxicities, including toxicity, diarrhea, inflammation of the colon and lung and perforation of the intestine. (Reporting by Toni Clarke in Washington; Editing by Susan Heavey)

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