Drugs

Gilead Misses on Trodelvy Confirmatory Study

Gilead Sciences says it will be discussing with FDA the continued marketing of its accelerated-approval Trodelvy (sacituzumab govitecan-hziy) in patients with metastatic urothelial cancer following topline results from a Phase 3 confirmatory trial that showed the therapy did not meet the primary endpoint of overall survival (OS) in the intention-to-treat population. “A numerical improvement in OS favoring Trodelvy was observed, and trends in improvement for select pre-specified subgroups and secondary endpoints of progression-free survival (PFS) and overall response rate (ORR) were also shown,” the company says. “The pre-specified subgroup analyses were not alpha-controlled for formal statistical testing.”

Gilead also says that in the overall study population, there was a higher number of deaths due to adverse events with Trodelvy compared to the treatment of physicians’ choice, which were mainly seen early in treatment and related to neutropenic complications, including infection. The company says it will further investigate thee data, and is working to reiterate to treating physicians the importance of granulocyte-colony stimulating factor use for the prevention of neutropenic complications. A Boxed Warning already exists for severe or life-threatening neutropenia, it notes.

Trodelvy is described as a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types. “Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload,” the company says. “This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.”

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