Drugs

FDA Accelerated Approval for Immunomedics’ Trodelvy

FDA granted accelerated approval 4/13 to Immunomedics’ Trodelvy (sacituzumab and govitecan) for patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. An agency notice says Trodelvy’s safety and efficacy were evaluated in the TROPHY trial that enrolled 112 patients with the main efficacy endpoints of objective response rate and duration of response.

The indication was approved under accelerated approval based on tumor response rate and duration of response, FDA says. Continued approval for the indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

The agency review used the Real-Time Oncology Review pilot program, which streamlined data submission before the filing of the entire clinical application, and the Assessment Aid, a voluntary applicant submission to facilitate FDA assessment. The application was approved six weeks before the goal date.

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