Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer

 Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer

Merck and Ridgeback Report the Initiation of EMA Rolling Review of Molnupiravir for the Treatment of COVID-19

Shots:

  • The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
  • The approval is based on the P-III KEYNOTE-826 trial that demonstrated superior OS and PFS, ORR (68% vs 50%), mDOR (18.0 vs 10.4mos.)
  • The approval marks the first anti-PD-1 combination approved as a 1L treatment for the targeted patients. Additionally, the FDA converted the accelerated approval of Keytruda as a single agent for recurrent or metastatic cervical cancer to a regular approval based on data from KEYNOTE-826 study

Click here to­ read full press release/ article | Ref: Businesswire | Image: The Conversation