Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma

July 6, 2021 Auto Bot approval, FDA, KEYTRUDA, Merck, pembrolizumab, regulatory 0

Shots:

  • The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA cSCC that is not curable by surgery or radiation
  • Results: ORR (50%); CR (17%); PR (33%), 81% had DOR of 6mos. or longer, and 37% had a DoR of 12mos. or longer, @median follow-up of 13.4mos., m-DoR had not reached & median duration of exposure was 6.9 mos.
  • Keytruda is an anti-PD-1 therapy, acts by increasing the ability of the body’s immune system to help detect and fight tumor cells. In Jun’20, the therapy marks the first indication in recurrent or metastatic cSCC

Click here to read full press release/ article | Ref: Businesswire | Image: Drug Dangers

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