FDA Grants Priority Review to Sarclisa for Treatment of Multiple Myeloma

Sanofi-Aventis announced that the FDA has granted priority review to Sarclisa, in combination with VRd chemotherapy, to treat newly diagnosed multiple myeloma patients who are not eligible for transplantation.

This decision is based on the positive results of the phase III IMROZ study. If approved, Sarclisa would become the first anti-CD38 to be used in this setting. The FDA is due to make its decision on September 27, 2024.

Results from the IMROZ study, demonstrating a significant improvement in progression-free survival, will be presented at the 2024 ASCO Annual Meeting.

The license application is also being evaluated in the European Union. If approved, Sarclisa would be administered in combination with bortezomib, lenalidomide and dexamethasone.