Biologics

sBLA for Padcev–Keytruda Combo in Bladder Cancer

FDA has accepted for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda (pembrolizumab) for treating cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). The submission seeks approval for the regimen as both a neoadjuvant treatment before surgery and an adjuvant therapy afterward, according to the company. The agency set a user fee review action target date of 4/7.

Padcev is described as an antibody-drug conjugate targeting Nectin-4, a protein highly expressed in bladder cancer. It is currently approved — alone and in combination with Keytruda — for locally advanced or metastatic urothelial cancer. The new filing aims to move the regimen into earlier-stage disease, where curative potential remains highest.

The sBLA is based on data from the Phase 3 EV-303 (KEYNOTE-905) trial, which showed that the Padcev–Keytruda combo cut the risk of recurrence, progression, or death by 60% and the risk of death by 50% compared with surgery alone in cisplatin-ineligible MIBC patients, the company says. Safety findings were consistent with prior studies of the regimen, with no new safety signals reported.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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