FDA approves pembrolizumab for TMB-H solid tumors

The U.S. Food and Drug Administration has approved pembrolizumab (Keytruda) as monotherapy 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.

“For the second time, KEYTRUDA monotherapy is now approved based on a biomarker rather than the location in the body where the tumor originated,” said Dr Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories, in a press release. “TMB-H, defined as 10 mutations per megabase or more, can help identify patients most likely to benefit from KEYTRUDA. We’re pleased that our collaborative efforts to advance biomarker research have resulted in our ability to provide a new treatment option that addresses a high unmet medical need for these patients with cancer.”

Read the full press release here.