ODAC gives thumbs down to single-arm trial of two-drug combination for multiple myeloma

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It’s not just the absence of a randomized trial that prompted the FDA Oncologic Drugs Advisory Committee to recommend against an accelerated approval of the Karyopharm Therapeutics Inc. drug selinexor for late-stage multiple myeloma.

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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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