MSD has received US FDA approval for pembrolizumab (Keytruda) and pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with paclitaxel, with or without bevacizumab.[1] The approval is for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) by an FDA-authorized assay.[1] Patients must have received one or two prior systemic treatment regimens.[1] At the same time, the FDA approved the PD-L1 IHC 22C3 pharmDx test (Agilent Technologies) as a companion diagnostic to identify suitable patients.[1] Efficacy was assessed in the multicenter, randomized, double-blind study KEYNOTE-B96 (NCT05116189) in 643 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one or two prior lines of therapy.[1] The primary efficacy measure was progression-free progression (PFS) as assessed by RECIST v1.1, with overall survival (OS) as the secondary measure.[1] The safety profile of the combination of pembrolizumab with paclitaxel, with or without bevacizumab, was similar to previous studies in cancer patients.[1] Prescribing information for Keytruda and Keytruda Qlex will be posted at Drugs@FDA.[1]