publication date: Oct. 13, 2017
Conversation with the Cancer Letter
Lemery: “We saw consistent evidence of the drug’s response in multiple tumor types”
Division of Oncology Products 2, FDA Office of Hematology and Oncology Products
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.
The agency decided against taking the application to the Oncologic Drugs Advisory Committee, Lemery said.
“For this approval, 1) we saw consistent evidence of the drug’s response in multiple tumor types 2) the underlying science for how to target this biomarker was demonstrated, and 3) patients with this genetic feature (MSI-H and mismatch-repair deficiency) had a lack of approved therapeutic options available,” he said. “Furthermore, pembrolizumab had already been approved for multiple other cancer indications; therefore, sufficient safety data already existed as well as an understanding of the efficacy of this class of checkpoint inhibitors.”
However, the agency decided to write a “perspective” piece in the New England Journal of Medicine “to help explain our rationale in what was a first-of-its-kind drug approval and outline what we see as challenges and opportunities to this approach moving forward,” he said.
Lemery spoke with Paul Goldberg, editor and publisher of The Cancer Letter.
… Continue reading Lemery: “We saw consistent evidence of the drug’s response in multiple tumor types”
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