Merck Wins FDA Approval for KEYTRUDA Regimen in PD-L1-Positive Platinum-Resistant Ovarian Cancer
Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX in PD-L1-positive platinum-resistant ovarian cancer. The decision marks the first approval of a PD-1 inhibitor regimen for this setting.
Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for adults with PD-L1 positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma after one or two prior systemic treatments. This marks the first approval of a PD-1 inhibitor regimen for this hard-to-treat setting, broadening KEYTRUDA’s reach in women’s cancers and reinforcing Merck’s oncology franchise.
The approval was described as a new first in class approval for platinum resistant ovarian cancer. It strengthens the near term oncology catalyst, but it does not remove the central risk around KEYTRUDA’s eventual loss of exclusivity and broader drug pricing pressure.
Merck’s 2026 guidance was for US$65.5 billion to US$67.0 billion in sales. The ovarian cancer approval was framed as incremental support for management’s growth plans, but within a portfolio that also faces headwinds such as weaker Gardasil demand in China and ongoing concerns about concentration in KEYTRUDA.
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