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Merck: FDA Approves Second Biomarker-Based Indication For KEYTRUDA

Merck (MRK) announced the FDA has approved KEYTRUDA as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The indication is approved under accelerated approval.

"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 Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

The FDA also approved FoundationOne CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H who may benefit from immunotherapy treatment with KEYTRUDA monotherapy.

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