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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President Joe Biden’s proposed Advanced Research Projects Agency-Health would be a welcome partner to NCI—particularly in conducting large, collaborative clinical investigations, NCI Director Ned Sharpless said.“I think having ARPA-H as part of the NIH is good for the NCI,” Sharpless said April 11 in his remarks at the annual meeting of the American Association for Cancer Research. “How this would fit with the ongoing efforts in cancer at the NCI is still something to work out.”
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