Criticism won’t slow targeted cancer drug reviews: FDA official

Bloomberg

18 October 2019 - FDA’s accelerated approval pathway has faced criticism it’s not really helping patients.

New cancer therapies targeted at smaller groups of patients will still speed through FDA review despite criticisms that they don’t always beat existing treatments, the agency’s oncology chief said.

As advances in science allow drug companies to develop a treatment tailored to a patient’s unique cancer, the Food and Drug Administration needs to remain flexible in how it approves those medicines, Richard Pazdur, the director of the agency’s Oncology Center of Excellence, said at a cancer event on 17 October.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Regulation , Timelines