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

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Ref: Merck | Image: Merck