Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #biomarker #fda #immunotherapy #merck #priorityreview
PRICENTRIC BRIEF:
- The application is for Merck’s Keytruda (pembrolizumab) as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) greater than or equal to 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options
- Results from the Phase 2 KEYNOTE-158 trial, which previously supported Merck’s 2017 FDA approval for Keytruda as the first cancer treatment based on a biomarker, regardless of tumor type, served as the basis for this most recent submission as well
- The FDA set a Prescription Drug User Fee Act (PDUFA) for Keytruda for June 16, 2020
THE DETAILS
WASHINGTON, D.C., The United States – Merck submitted a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) to the US Food and Drug Administration (FDA), which granted it priority review.
The application is for Keytruda as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) greater than or equal to 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 the target action date, or Prescription Drug User Fee Act (PDUFA), for Keytruda for June 16, 2020.
Results from the Phase 2 KEYNOTE-158 trial, which previously supported Merck’s 2017 FDA approval for Keytruda as the first cancer treatment based on a biomarker, regardless of tumor type, served as the basis for this most recent submission as well.
Dr. Scot Ebbinghaus, Vice President, Clinical Research, Merck Research Laboratories, said, “From the start, biomarker research has been a critical aspect of our clinical program evaluating Keytruda monotherapy. TMB 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.”
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