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AstraZeneca's immunotherapy enters U.S. approval process
December 9, 2016 / 5:07 PM / 10 months ago

AstraZeneca's immunotherapy enters U.S. approval process

A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. REUTERS/Phil Noble/File Photo

FRANKFURT (Reuters) - AstraZeneca’s immunotherapy drug durvalumab, the British drugmaker’s most important pipeline medicine, has been accepted for review by U.S. regulators against bladder cancer, potentially its first use.

The U.S. Food and Drug Administration also granted priority review status to the medicine, the company said, meaning trial data will be reviewed within six months instead of the usual 10. The drug boosts the immune system’s ability to fight cancerous cells.

Durvalumab is being tested on its own and in combination with another immune system-boosting drug called tremelimumab in various cancers, including lung cancer, which represents the biggest market.

Reporting by Ludwig Burger; Editing by Adrian Croft

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