Also known as: berahyaluronidase alfa-pmph
Berahyaluronidase alfa-pmph is part of the fixed-dose subcutaneous combination pembrolizumab and berahyaluronidase alfa-pmph, marketed as Keytruda Qlex. The U.S. FDA approved this product for subcutaneous use in September 2025 for solid tumor indications aligned with approved intravenous pembrolizumab uses. The product is positioned as a PD-1-based oncology immunotherapy combination delivered subcutaneously.
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
FDA approved pembrolizumab with paclitaxel, with or without bevacizumab, for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with PD-L1 CPS ≥1, based on KEYNOTE-B96 trial results.
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
The FDA approved pembrolizumab in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1).
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
