Article
FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Sept 2021
Marcus Leigh, Fashoyin-Aje Lola A, Donoghue Martha, Yuan Mengdie, Rodriguez Lisa, Gallagher Pamela S, Philip Reena, Ghosh Soma, Theoret Marc R, Beaver Julia A, Pazdur Richard, Lemery Steven J
Abstract excerpt
The FDA approved pembrolizumab on June 16, 2020, for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [TMB-H; ≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. FDA granted the approval based on a clinically...
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