FDA Policy/General

Padcev-Keytruda Combo for Broader Bladder Cancer

FDA has accepted for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to expand use of a combination regimen for patients with muscle-invasive bladder cancer (MIBC).

The application covers Padcev’s perioperative use in combination with Merck’s Keytruda, a PD-1 inhibitor. If approved, the regimen would be available to MIBC patients regardless of their eligibility for cisplatin chemotherapy, significantly broadening its use, according to the companies.

The combination was previously approved in 11/2025 for patients ineligible for cisplatin. The new filing aims to extend that indication to all patients with MIBC, potentially establishing what the companies describe as a new perioperative standard of care.

The submission is based on data from the Phase 3 EV-304 trial, also known as KEYNOTE-B15, which evaluated the combination in patients eligible for cisplatin-based chemotherapy. Recent data presented at the ASCO Genitourinary Cancers Symposium showed the regimen reduced the risk of disease recurrence, progression, or death by 47% compared with standard neoadjuvant chemotherapy with gemcitabine and cisplatin, according to the companies.

The combination also demonstrated a 35% reduction in the risk of death and a higher pathological complete response rate — 55.8% versus 32.5% for chemotherapy — at the time of surgery.

Safety findings were consistent with prior experience for the combination, with no new safety signals identified, they say.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome