Merck Receives the US FDA’s Priority Review for Keytruda’s (pembrolizumab) sBLA Based on Biomarker Regardless of Tumor Type

Merck Receives the US FDA’s Priority Review for Keytruda’s (pembrolizumab) sBLA Based on Biomarker Regardless of Tumor Type

Shots:

  • The sBLA is based on P-II KEYNOTE-158 study assessing Keytruda (200mg, q3w) in patients with solid tumors. The study also supported Merck’s 2017 FDA approval for Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in MSI-H or dMMR solid tumors
  • The application seeks accelerated approval of Keytruda as monothx. to treat adult and pediatric patients with unresectable or m-solid tumors with TMB-H ≥10 mutations/megabase, as determined by an FDA-approved test, progressed with following prior treatment and no satisfactory alternative treatment options with its anticipated PDUFA date as Jun 16, 2020
  • Keytruda is an anti-PD-1 therapy, act by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 thus activates T lymphocytes affecting both tumor and healthy cells

Click here ­to­ read full press release/ article | Ref: Merck | Image: Merck