FDA Approves Keytruda Regimen for Platinum-Resistant Ovarian Cancer
Published: 13 Mar 2026
Author: Precedence Research
In February 2026, Merck announced that the FDA approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant epithelial ovarian cancer, fallopian tube, or primary peritoneal carcinoma who have had one or two prior systemic treatments. These approvals are based on the Phase 3 KEYNOTE-B96 trial, which showed that KEYTRUDA plus paclitaxel significantly improved progression-free survival by 28% and overall survival by 24% compared to placebo plus paclitaxel.
KEYTRUDA QLEX™: New 1–2 Min Injection for PD-L1+ Ovarian Cancer
KEYTRUDA QLEX™ has received FDA approval for multiple solid tumor indications, including platinum-resistant ovarian cancer, based on studies demonstrating comparable efficacy, safety, and pharmacokinetic profiles to intravenous KEYTRUDA. As a 1–2 minute subcutaneous injection, it offers a faster alternative for patients, with studies showing similar overall response rates to the intravenous formulation.
Dr. Bradley Monk emphasized the importance of these options for patients with limited treatments after platinum resistance. KEYTRUDA QLEX is contraindicated in patients with hypersensitivity to its components and carries warnings for severe immune-mediated reactions, infusion-related reactions, and increased mortality in specific cases. Dr. Gursel Aktan highlighted the significance of these approvals for improving outcomes in ovarian cancer, showcasing Merck's commitment to innovative therapies.
According to Precedence Research, the fallopian tube cancer therapeutics market size accounted for USD 1.93 billion in 2025 and is predicted to increase from USD 2.14 billion in 2026 to approximately USD 5.41 billion by 2035, expanding at a CAGR of 10.86% from 2026 to 2035 as demand grows for targeted therapies, BRCA-mutation testing, and improved gynecological cancer screenings.
Key safety warnings for both formulations include severe to fatal immune-mediated adverse reactions, such as pneumonitis, colitis, and hepatitis, as well as infusion or injection-related reactions and embryo-fetal toxicity. The treatment is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa or hyaluronidase and is not recommended for use with thalidomide analogues in multiple myeloma.
Clinical Breakthrough and Standard of Care
The approval establishes the first immune-oncology regimen for PD-L1+ platinum-resistant fallopian tube, ovarian, and peritoneal cancers. This provides a new standard of care, significantly improving survival for patients with poor prognoses, along with driving biomarker-based, personalized treatment. This milestone intensifies competition in the gynecologic oncology market, shifting focus toward targeted, highly resistant disease therapies.
A recent report by Precedence Research highlights that the fallopian tube cancer therapeutics market is benefiting from rapid advancements in targeted therapies and precision medicine to address high-grade serous malignancies and increasing focus on women's health.