- FDA granted priority review for sBLAs of pembrolizumab and pembrolizumab+berahyaluronidase alfa‑pmph, each combined with enfortumab vedotin (Padcev); PDUFA target date August 17, 2026.
- Phase 3 KEYNOTE‑B15 (EV‑304) enrolled 808 cisplatin‑eligible MIBC patients randomized to perioperative pembrolizumab plus enfortumab vedotin with surgery and adjuvant therapy versus neoadjuvant gemcitabine‑cisplatin and surgery.
- Primary endpoint was event‑free survival; key secondary endpoints were overall survival and pathologic complete response.
- Study conducted in collaboration with Pfizer and Astellas; KEYTRUDA plus Padcev has shown overall survival benefit across three Phase 3 bladder‑cancer trials and is approved for certain la/mUC and cisplatin‑ineligible MIBC indications.
Regulatory update
FDA granted priority review for two supplemental BLAs for pembrolizumab and pembrolizumab+berahyaluronidase alfa‑pmph, each combined with enfortumab vedotin (Padcev) for cisplatin‑eligible muscle‑invasive bladder cancer; PDUFA target date is August 17, 2026.
KEYNOTE‑B15 trial results
KEYNOTE‑B15 (EV‑304) randomized 808 cisplatin‑eligible MIBC patients to perioperative pembrolizumab plus enfortumab vedotin with surgery and adjuvant therapy versus neoadjuvant gemcitabine‑cisplatin and surgery; the combination produced statistically significant and clinically meaningful improvements in event‑free survival (primary endpoint) and overall survival (key secondary), with pathologic complete response also evaluated.
Clinical context and next steps
If approved, these regimens would extend perioperative options to MIBC patients regardless of cisplatin eligibility, building on existing approvals of pembrolizumab plus Padcev for locally advanced/metastatic urothelial cancer and for cisplatin‑ineligible MIBC in the U.S.; the program has shown overall survival benefit across three Phase 3 bladder‑cancer trials (including KEYNOTE‑905 and KEYNOTE‑A39) and the study was conducted in collaboration with Pfizer and Astellas.
