April 07, 2020
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FDA grants priority review to Keytruda for patients with high tumor mutational burden

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The FDA granted priority review to pembrolizumab for treatment of adults and children with unresectable or metastatic solid tumors that have high tissue tumor mutational burden.

The designation applies to use of pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — for patients whose tumors have at least 10 mutations per megabase as determined by an FDA-approved test, who progressed after prior treatment and who have no satisfactory alternative treatments.

The FDA is expected to make a decision on approval by June 16.

“From the start, biomarker research has been a critical aspect of our clinical program evaluating Keytruda monotherapy,” Scot Ebbinghaus, MD, vice president for clinical research with Merck Research Laboratories, said in a company-issued press release. “Tumor mutational burden has been an area of scientific interest to help identify patients most likely to benefit from Keytruda. We look forward to working with the FDA throughout the review process to help bring Keytruda monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited.”

The supplemental biologics license application is based in part on results of the nonrandomized, multicohort phase 2 KEYNOTE-158 trial.

Results, presented at least year’s European Society for Medical Oncology Congress, showed an association between tumor mutational burden and outcomes among patients with select advanced solid tumors who received pembrolizumab dosed at 200 mg every 3 weeks.