Home Alzheimer’s Disease FDA Grants Priority Review to Pembrolizumab Monotherapy for TMB-High Tumors

FDA Grants Priority Review to Pembrolizumab Monotherapy for TMB-High Tumors

The FDA granted priority review to a new supplemental biologics license application (sNDA) for pembrolizumab (Keytruda), according to Merck, the agent’s developer.1

The sNDA is seeking accelerated approval of pembrolizumab monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) ≥10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options. 

The FDA set a prescription drug user fee act (PDUFA) date of June 16, 2020. 

“From the start, biomarker research has been a critical aspect of our clinical program evaluating Keytruda monotherapy,” Scott Ebbinghaus, MD, vice president of clinical research at Merck, said in a press release.2“TMB has been an area of scientific interest…

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