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.