FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Gives Priority Review to Keytruda

Feb. 20, 2019

The FDA granted priority review for Merck’s supplemental BLA for its blockbuster immunotherapy Keytruda (pembrolizumab) for head and neck cancers.

Keytruda is already approved as a second-line treatment for head and neck cancer and several other forms of the disease. The drug has shown “significant improvement” for head-or-neck cancer patients’ overall survival in a Phase 3 trial, the company said.

“Merck continues to make meaningful advances in the treatment of head and neck cancer, and we look forward to working with the FDA to bring these important new options to patients in the first-line setting.” said Jonathan Cheng, vice president of clinical research at Merck Research Laboratories.

The FDA committed to completing the priority review no later than June 10.

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