Press Release: Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
FDA Priority Review granted based on positive results from IMROZ phase 3 study
If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care treatment for patients with newly diagnosed transplant-ineligible multiple myeloma
Pivotal IMROZ phase 3 study results to be featured during oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Paris, May 27, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible...