Drugs

FDA Expands Pluvicto Approval to Earlier-Stage Prostate Cancer

FDA has approved Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen- (PSMA) positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, broadening the radiopharmaceutical's use into an earlier stage of the disease.

The expanded approval allows Pluvicto to be used in patients whose tumors express PSMA before they have developed resistance to hormone-based therapies. Patients must be selected using Locametz (gallium Ga 68 gozetotide) or another FDA-approved PSMA positron emission tomography imaging agent to confirm PSMA expression.

FDA says the approval was supported by results from the Phase 3 PSMAddition trial, which enrolled 1,144 patients with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. Participants were randomized to receive Pluvicto plus an investigator-selected ARPI or ARPI therapy alone. The study met its primary endpoint, demonstrating a statistically significant improvement in radiographic progression-free survival. Median progression-free survival had not been reached in either treatment arm at the time of analysis, but the combination reduced the risk of radiographic disease progression or death by 28% compared with ARPI therapy alone.

Pluvicto’s prescribing information includes warnings for radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, infertility, and other risks associated with radioligand therapy.

Pluvicto was previously approved for patients with more advanced PSMA-positive metastatic castration-resistant prostate cancer. The latest approval significantly expands its use by allowing treatment earlier in the course of metastatic disease, potentially providing patients access to targeted radioligand therapy before progression to hormone-resistant cancer.

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