FDA Approves KEYTRUDA for Platinum-Resistant Ovarian Cancer

The FDA approved KEYTRUDA and its subcutaneous QLEX formulation for platinum-resistant ovarian cancer, making KEYTRUDA the first PD-1 inhibitor cleared for this difficult ovarian cancer population. The approval was supported by Phase 3 results.

Fresh oncology data is heading to the 2026 ASCO GU symposium. The upcoming genitourinary presentations highlight how central oncology remains to Merck's long-term story.

The latest KEYTRUDA approval arrives after a strong run in the stock, with a 30.75% 90 day share price return and a 51.76% 1 year total shareholder return from a last close of US$121.41. Shares are only about 3% below the average analyst price target.

The broader PD-1/PD-L1 checkpoint inhibitors market expanded from USD 57.77 billion in 2025 to USD 59.53 billion in 2026, and is projected to reach USD 85.83 billion by 2032, registering a strong CAGR of 5.81%. These figures reflect sustained adoption across oncology indications and robust investment in access and distribution initiatives.

New therapy combinations and biomarker-driven enrollment are making clinical differentiation essential in oncology portfolios. Payers and regulators are increasingly prioritizing long-term clinical value, real-world outcomes, and health economics data over narrow efficacy metrics.

Distribution models are transitioning, with specialty and digital channels playing a greater role in patient access and adherence strategies. Regional divergence in reimbursement and procurement requires tailored dossiers, strategic partnerships, and flexible operational plans.

Leading products in the checkpoint inhibitor class include Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, and Pembrolizumab, benchmarked for safety, combination use, companion diagnostics, and market reach. Clinical indications span Hodgkin Lymphoma, Melanoma, Non Small Cell Lung Cancer, Renal Cell Carcinoma, and Urothelial Carcinoma.

Manufacturers that integrate digital patient support and multi-source real-world evidence platforms are better positioned for commercial success. Collaborative alliances between global biopharma and in-market partners are accelerating entry and overcoming infrastructure barriers.