Biologics

Sanofi Sarclisa sBLA Accepted for Priority Review

FDA has accepted for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM). According to the company, if approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care VRd in this patient population. The user fee review action target date is 9/27.

The submission is based on data from the IMROZ Phase 3 clinical study. In 12/2023, the study met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival with Sarclisa in combination with VRd compared with VRd alone in transplant-ineligible patients with NDMM, Sanofi says. “The safety and tolerability of Sarclisa observed in this study was consistent with the established safety profile of Sarclisa and VRd,” it adds.

Sarclisa is described as a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death and immunomodulatory activities, Sanofi says.

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