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

October 14, 2021 Auto Bot approval, cervical cancer, FDA, KEYTRUDA, Merck, pembrolizumab, regulatory 0

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

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