FDA panel turns down fast-track approval of AstraZeneca cancer drug

FDA

AstraZeneca failed to win accelerated approval of a cancer drug in the U.S., dealing a blow to its new drug-development pipeline, a key plank of its defense in fighting off a $120 billion approach from Pfizer Inc. last month.

The company said an advisory committee to the U.S. Food and Drug Administration voted 11-2 against accelerated approval of its experimental ovarian cancer drug olaparib in patients with a specific mutation of the disease.

The FDA isn't obliged to follow the committee's recommendations, although it often does.

Olaparib is one of a host of new cancer treatments AstraZeneca is hoping will become the mainstay of its business, reducing its current reliance on heart, lung and diabetes drugs.

For more details, go to: http://online.wsj.com/articles/fda-turns-down-fast-track-approval-of-astrazeneca-cancer-drug-1403773752

Michael Wonder

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Michael Wonder

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