Merck & Co. (MRK) Announces FDA Approval of KEYTRUDA® and KEYTRUDA QLEX™ Plus Paclitaxel, With or Without Bevacizumab, to Treat Adults With PD-L1+

Core Insights - Merck & Co., Inc. (NYSE:MRK) has received FDA approval for KEYTRUDA® and KEYTRUDA QLEX™ for treating adults with PD-L1+ platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, marking a significant advancement in cancer treatment [1][2] Group 1: FDA Approval and Treatment Efficacy - The FDA approval was based on the Phase 3 KEYNOTE-B96 trial, which demonstrated that the KEYTRUDA regimen reduced the risk of disease progression or death by 28% and the risk of death by 24% compared to placebo plus paclitaxel with or without bevacizumab [2] - KEYTRUDA and KEYTRUDA QLEX are the first and only PD-1 inhibitors approved for the specified cancer types with PD-L1+ tumors [1][2] Group 2: Research and Development - The effectiveness of KEYTRUDA QLEX for its approved indications is supported by well-controlled studies conducted with KEYTRUDA, along with additional data comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA [3] Group 3: Company Overview - Merck & Co., Inc. is a biopharmaceutical company focused on advancing the treatment and prevention of diseases in both animals and humans, with its Pharmaceutical segment offering vaccines and human health pharmaceutical products [4]