The U.S. Food and Drug Administration approved Keytruda (pembrolizumab) and its subcutaneous formulation Keytruda Qlex (pembrolizumab with berahyaluronidase alfa‑pmph) in combination with paclitaxel, with or without bevacizumab, for adults with PD‑L1+ (CPS ≥ 1) platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. The approval, announced on February 10, 2026, grants Merck a first‑in‑class entry into a disease area with limited treatment options and a poor prognosis.
The approval is backed by the Phase 3 KEYNOTE‑B96 trial, which showed a median progression‑free survival of 8.3 months versus 7.2 months for the control arm, a 28 % lower risk of progression, and a median overall survival of 18.2 months versus 14 months, a 24 % lower risk of death. These data demonstrate a clinically meaningful benefit for patients who have exhausted standard platinum‑based chemotherapy.
Keytruda has been a cornerstone of Merck’s oncology portfolio, with family sales of $8.4 billion in Q4 2025 and $29.482 billion in 2024, up 18 % from the prior year. The new indication adds a high‑margin revenue stream that complements the $40 million in 2025 sales of Keytruda Qlex and positions Merck to capture a growing market as other PD‑1/PD‑L1 inhibitors face patent expirations and competitive pressure. The approval also supports Merck’s strategy to diversify beyond its flagship product by expanding into new therapeutic areas and leveraging its subcutaneous platform.
Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, said, “These approvals mark an important moment for the ovarian cancer community, reflecting years of focused investment in KEYTRUDA. Introducing the first PD‑1 inhibitor for platinum‑resistant ovarian cancer means we’re expanding what’s possible for patients facing this disease, and it reinforces our commitment to advancing innovative therapies across women’s cancers.”
The approval comes at a time when Merck’s 2026 guidance—projected revenue of $65.5 billion to $67 billion and adjusted EPS of $5.00 to $5.15—was below analyst expectations, reflecting concerns over upcoming patent expirations and acquisition spending. Nonetheless, the new indication strengthens Merck’s oncology pipeline, offers a competitive edge over rivals such as Opdivo, Tecentriq and Imfinzi, and provides a tailwind for future growth in a high‑need market.
The FDA’s decision to approve the combination therapy, coupled with the companion diagnostic PD‑L1 IHC 22C3 pharmDx, underscores the importance of biomarker‑driven treatment and positions Merck to capture a sizable share of the platinum‑resistant ovarian cancer market, potentially translating into significant incremental revenue and reinforcing the company’s leadership in immuno‑oncology.
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