Drugs

FDA Approves Novartis’ Pluvicto for Prostate Cancer

FDA approved 3/23 Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. An agency notice says concurrent approval was granted for the company’s Locametz (gallium Ga 68 gozetotide), a radioactive diagnostic agent for positron emission tomography of PSMA-positive lesions, including the selection of patients with metastatic prostate cancer for whom Pluvicto therapy is indicated. FDA says Locametz is the first radioactive diagnostic agent approved for patient selection in the use of a radioligand therapeutic agent.

Pluvicto efficacy was evaluated in the VISION trial that FDA says demonstrated a statistically significant improvement in the primary endpoints of overall survival and radiographic progression-free survival.

The notice says the most common adverse reactions to Pluvicto were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation.

The agency review used the Assessment Aid, a voluntary submission from Novartis to facilitate the agency’s assessment. The application had been granted priority review and breakthrough designation.

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