The Priority Review

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FDA approvals

2 stories

  1. Approvals

    FDA grants traditional approval for pembrolizumab in TMB-H tumors; 36% had an objective response

    The FDA granted traditional approval to pembrolizumab for TMB-H solid tumors; the objective response rate was 36% (95% CI: 30, 43) in 220 patients in KEYNOTE-158. The approval defines TMB-H as 13 or more mut/Mb, up from the 10 mut/Mb used in the accelerated approval.

  2. Approvals

    FDA approves first generic of Climara Pro, a once-weekly estradiol and levonorgestrel patch

    The FDA approved the first generic of Climara Pro, an estradiol and levonorgestrel transdermal system (0.045 mg per day/0.015 mg) applied once a week. The FDA said the generic is therapeutically equivalent to Climara Pro.