Merck’s Keytruda (pembrolizumab) Receives Expanded Label Approval for 1L nonsq. mNSCLC, with No EGFR and ALK Genomic Tumor

 Merck’s Keytruda (pembrolizumab) Receives Expanded Label Approval for 1L nonsq. mNSCLC, with No EGFR and ALK Genomic Tumor

Merck’s Keytruda sBLA Receives FDA Priority Review for Treatment of Locally Advance or mMCC

Shots:
  • Approval is based on KEYNOTE-189, Ph III study where Keytruda combined with ALIMTA and Pt. CT showed improved results vs CT
  • KEYNOTE-189 (Keytruda +pemetrexed and Pt. CT vs CT alone): mPFS (8.8 vs 4.9mos); ORR (48% vs 19%); mDOR (11.2 vs 7.8mos); reducing death risk by half
  • Keytruda was first approved in 2017 in combination with pemetrexed and carboplatin by FDA for 1L nonsq. mNSCLC from Ph II (KEYNOTE-021)

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

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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