Drugs

FDA Expands Approval of Keytruda-Enfortumab Vedotin Regimen

FDA has expanded the indication for Merck's Keytruda (pembrolizumab), including its subcutaneous formulation Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Astellas Pharma's Padcev (enfortumab vedotin-ejfv) for treating muscle-invasive bladder cancer (MIBC). The approval extends the regimen's use beyond patients who are ineligible for cisplatin chemotherapy to all adults with MIBC who are candidates for radical cystectomy. Under the expanded indication, the combination is approved as perioperative therapy, consisting of neoadjuvant treatment before bladder removal surgery followed by adjuvant treatment after cystectomy.

The decision was supported by data from the Phase 3 KEYNOTE-B15/EV-304 trial, which enrolled 808 previously untreated patients with muscle-invasive bladder cancer who were eligible for cisplatin-based chemotherapy and planned to undergo radical cystectomy with pelvic lymph node dissection, according to FDA.

Patients were randomized to receive perioperative pembrolizumab plus enfortumab vedotin or standard neoadjuvant gemcitabine and cisplatin before surgery. FDA says the study met its primary endpoint, demonstrating a statistically significant improvement in event-free survival (EFS). Median EFS had not been reached in the pembrolizumab-enfortumab vedotin arm, compared with 48.5 months for patients receiving gemcitabine and cisplatin, representing a 47% reduction in the risk of disease recurrence, progression, or death, it adds.

The combination also demonstrated a statistically significant overall survival benefit, according to the agency. Median overall survival had not been reached in either treatment arm at the time of analysis, with patients receiving pembrolizumab and enfortumab vedotin experiencing a 35% reduction in the risk of death compared with chemotherapy.

According to the FDA, the safety profile of the combination in KEYNOTE-B15/EV-304 was consistent with previous studies of pembrolizumab and enfortumab vedotin in urothelial cancer. The prescribing information for Keytruda includes boxed warnings and precautions related to immune-mediated adverse reactions, infusion-related reactions, complications following allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. Padcev's labeling carries warnings for severe skin reactions, hyperglycemia, pneumonitis and interstitial lung disease, peripheral neuropathy, ocular disorders, infusion site 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