FDA approves Merck bladder cancer combo; trial tests abatacept for checkpoint inhibitor myocarditis

The U.S. Food and Drug Administration approved Merck's pembrolizumab (Keytruda) in combination with enfortumab vedotin (Padcev) as neoadjuvant and adjuvant therapy for adults with muscle‑invasive bladder cancer, regardless of cisplatin eligibility. The approvals, based on the Phase 3 KEYNOTE‑B15 and KEYNOTE‑905 trials, mark the first PD‑1 inhibitor plus antibody‑drug conjugate regimen for this indication.

Separately, the CU Anschutz Cancer Center launched a clinical trial to evaluate abatacept alongside corticosteroids for treating checkpoint inhibitor‑associated myocarditis, a rare but potentially fatal cardiac inflammation linked to immune checkpoint cancer therapies. The study aims to determine whether early abatacept infusion improves cardiac outcomes and provides a standardized treatment algorithm for this side effect.