Sanofi announces that the U.S. FDA has granted priority review to its supplemental biologics license application for Sarclisa, to treat patients with newly diagnosed multiple myeloma not eligible for transplantation.

This decision is motivated by the results of the Phase III IMROZ study, which evaluated the investigational use of Sarclisa in combination with reference VRd chemotherapy, and demonstrated a statistically significant improvement in progression-free survival.

The FDA is expected to make its final decision on September 27, and if approved, this would be Sarclisa's third indication for the treatment of multiple myeloma. A regulatory submission is also being considered in the European Union.

Copyright (c) 2024 CercleFinance.com. All rights reserved.