Sanofi's Sarclisa gets rapid FDA review for front-line myeloma

The FDA has prioritized the review of Sanofi's application for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM) patients who are not eligible for stem cell transplant. A decision on this application is anticipated by September 27. Sanofi's Chief Medical Officer, Dietmar Berger, emphasized the persistent need for new frontline treatments, especially for patients who cannot undergo transplants, despite recent medical progress. If approved, Sarclisa would be the first anti-CD38 therapy combined with the standard VRd treatment for this patient group.

The application is backed by results from the Phase III IMROZ study. In a planned interim analysis of the trial, the combination of Sarclisa and VRd achieved the primary goal of improved progression-free survival compared to VRd alone, and it also showed a favorable safety and tolerability profile. Detailed results from this study will be presented at the upcoming American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) conferences.

Sarclisa has already been approved in several countries, including the United States, for use in combination with Bristol-Myers Squibb's Pomalyst (pomalidomide) and dexamethasone in third-line relapsed or refractory MM. This approval was later extended to include its combination with Amgen's Kyprolis (carfilzomib) and dexamethasone for patients who have received one to three prior lines of therapy.

Last year, Sarclisa generated global sales of €381 million ($413 million). It is also being evaluated in several late-stage studies alongside standard treatments across the MM spectrum and other hematologic malignancies.