Lemery: “We saw consistent evidence of the drug’s response in multiple tumor types”

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The application for approval of Keytruda (pembrolizumab) was based on internal discussions within FDA as well as working “proactively with the sponsor to submit this application,” said Steven Lemery, associate director, Division of Oncology Products 2, FDA Office of Hematology and Oncology Products.

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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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