Q2 2026 in Oncology: A Look Back at FDA Approvals and Decisions
FDA oncology Q2 2026 brings major breast, prostate and kidney cancer approvals, split ODAC votes, and RP1 melanoma setback heading into Q3.
The second quarter of 2026 turned out to be one of the busier stretches of the year for FDA oncology activity, bookended by 2 notable advisory committee votes and a steady cadence of approvals in breast, prostate, and kidney cancer. The quarter also delivered its share of setbacks, most notably a second rejection for Replimune's oncolytic immunotherapy RP1, underscoring that not every closely watched application crossed the finish line. By the time June closed out, several of the threads left open during the quarter, including RP1's third attempt and a manufacturing-related delay for a neuroendocrine tumor imaging agent, were already rolling into Q3.