FDA Expands MIBC Approval: What Changed for Platinum-Eligible Patients

In this video, Joshua J. Meeks, MD, PhD, the Edward M. Schaeffer, MD, PhD Professor of Urology and associate professor of urology, biochemistry, and molecular genetics at Northwestern University Feinberg School of Medicine in Chicago, Illinois, explains that on July 10, 2026, the FDA broadened its approval of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keyruda) to cover cisplatin-eligible patients with MIBC who are cystectomy candidates, closing a gap left by the drug's original approval.¹

That first approval, granted in November 2025, covered only platinum-ineligible patients based on the EV-303 trial. Meeks notes that roughly 15% to 20% of patients enrolled in that trial were actually platinum-eligible but platinum-refusing, leaving a group of technically eligible patients without a clear FDA-approved pathway to the regimen—even though KEYNOTE B-15/EV-304 data presented at ASCO GU in February 2026 had already shown a favorable event-free survival HR of 0.53 vs chemotherapy. With the expanded approval, he says, the distinction between platinum-eligible, platinum-ineligible, and even metastatic disease largely disappears: Essentially all these patients can now start the same two-drug regimen without extended eligibility discussions.

Meeks also highlights that the expanded approval includes a subcutaneous formulation of pembrolizumab, co-formulated with berahyaluronidase alfa-pmph, as an alternative to the standard intravenous infusion. He explains that this matters practically because IV infusions require dedicated infusion chairs, a resource constraint at many centers. A subcutaneous option doesn't reduce the need to monitor for adverse events, he cautions, but it does reduce the burden on infusion-center capacity—a change he sees as especially meaningful for patients in rural communities who often lack easy access to infusion sites.

In the next episode, "What the Efficacy Data from KEYNOTE-B15/EV-304 Revealed," Meeks digs into the trial data behind this shift, walking through how the combination regimen compares to decades of platinum-based standard care.

REFERENCE

1. FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer. News release. US Food & Drug Administration. July 10, 2026. Accessed July 10, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin