Sanofi: FDA priority approval for Sarclisa


(AOF) – Sanofi indicated that the American Food and Drug Administration (FDA) had granted priority review to the drug Sarclisa. If approved, it could be the first anti-CD38, in combination with standard-of-care chemotherapy, for patients with newly diagnosed multiple myeloma who are not eligible for transplantation. This would be the third indication for Sarclisa for the treatment of multiple myeloma. The FDA is expected to make its decision on September 27, 2024. A regulatory submission is also under consideration in the European Union.

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