FDA approves pembrolizumab for adults and children with TMB-H solid tumors


Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [‚Č•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. More Information. June 16, 2020


 Hematology/Oncology (Cancer) Approvals & Safety Notifications


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