Reported Monday, Sanofi's Sarclisa Accepted For FDA Priority Review For Treating Transplant-Ineligible Newly Diagnosed Multiple Myeloma
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Sanofi's Sarclisa has been accepted for FDA priority review for treating transplant-ineligible newly diagnosed multiple myeloma, based on positive results from the IMROZ phase 3 study. If approved, it would be the first anti-CD38 therapy in combination with standard-of-care treatment for this patient group.
May 28, 2024 | 7:13 am
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Sanofi's Sarclisa has been accepted for FDA priority review for treating transplant-ineligible newly diagnosed multiple myeloma. This acceptance is based on positive results from the IMROZ phase 3 study, and if approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care treatment for this patient group.
The FDA priority review acceptance is a significant milestone for Sanofi, indicating a potentially faster approval process. Positive results from the IMROZ phase 3 study further enhance the likelihood of approval, which could lead to increased market share and revenue for Sanofi.
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