Three companies withdraw cancer indications for PD-1/PD-L1 drugs in FDA’s “industry-wide evaluation”

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Over the past three months, three pharmaceutical companies voluntarily withdrew three cancer indications for drugs that had previously received accelerated approvals from FDA, but ultimately failed to meet agreed-upon endpoints in confirmatory trials required for regular approvals.

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Paul Goldberg
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Throughout my career as a physician and scientist, I’ve seen ideas once considered impossible become breakthroughs that save lives. They happened because talented scientists had the resources, institutions, and sustained support to pursue ambitious ideas. Most importantly, they knew patients could not afford to wait. 
Paul Goldberg
Editor & Publisher

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