The FDA approved six cancer therapies in Q2 2026, including first-line sacituzumab govitecan for triple-negative breast cancer and capivasertib for PTEN-deficient prostate cancer. A separate study shows 69% of accelerated-approval cancer drugs need safety updates within 4 years.
Four biomarkers—MMR, HER2, PD-L1, and Claudin 18.2—are now validated for advanced esophageal cancer, guiding immunotherapy and targeted treatment decisions. Checkpoint inhibitors show clear benefit in MSI-H and PD-L1-positive subgroups, with long-term survival observed. NCCN guidelines recommend broad testing to personalize therapy.
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.
The FDA has approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying esophageal cancer patients eligible for Merck's KEYTRUDA immunotherapy. This marks the eighth FDA-approved indication for this diagnostic test with KEYTRUDA. The test helps identify patients whose tumors express PD-L1 for potential treatment with the anti-PD-1 therapy.
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
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 plus paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian cancer based on phase 3 KEYNOTE-B96 trial results showing improved survival outcomes.
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.
