Drugs

Novartis Seeking Expanded Pluvicto Use

Novartis says it will seek FDA approval next year for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — to slow disease progression in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibition (ARPI) and before taxane-based chemotherapy. The drug is currently approved for treating adults with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with ARPI and taxane-based chemotherapy. The expanded indication will be based on Phase 3 data demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival, according to the company.

Novartis says Pluvicto is the first PSMA-targeted radioligand therapy to demonstrate clinically meaningful benefits for patients with this type of prostate cancer who have not received taxane-based chemotherapy. “Despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, and there is an urgent need for new targeted treatment options to help improve long-term outcomes,” it says.

Pluvicto is described as an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). “After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein,” Novartis says. “Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and triggering cell death.”

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