Drugs

Keytruda/Padcev Combo OK’d for Bladder Cancer

FDA has approved Merck’s checkpoint inhibitor pembrolizumab — administered as either Keytruda or the subcutaneous formulation Keytruda Qlex — in combination with Astellas and Pfizer’s antibody drug conjugate Padcev (enfortumab vedotin-ejfv) as a perioperative treatment for adults with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin chemotherapy. According to an FDA release, the regimen is now approved for use both before and after radical cystectomy with pelvic lymph-node dissection, marking the first approval of an immunotherapy-ADC combination in the curative-intent setting for MIBC.

FDA approval is based on data from the KEYNOTE-905/EV-303 study in 344 patients who were candidates for surgery but either could not receive or declined cisplatin-based chemotherapy. The combination significantly improved both event-free survival (the trial’s primary endpoint) and overall survival, according to the agency.

The agency says the safety profile of the pembrolizumab–Padcev combination was similar to that seen in metastatic urothelial cancer trials. Pembrolizumab’s labeling carries warnings for immune-mediated toxicities, severe infusion reactions, post-transplant complications, and embryo-fetal risk. Padcev’s labeling includes cautions for serious skin reactions, hyperglycemia, pneumonitis/ILD, neuropathy, ocular disorders, extravasation, and embryo-fetal toxicity.

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