FDA issues Complete Response Letter on Keytruda in TNBC indication

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FDA has issued a Complete Response Letter regarding Merck’s supplemental Biologics License Application seeking approval for Keytruda, Merck’s company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery.

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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.”