The U.S. Food and Drug Administration (FDA) granted isatuximab priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma (MM) in combination with bortezomib, lenalidomide, and dexamethasone (VRd). The target action date is set for September 27, 2024.
Priority review was granted based on the results of the global, randomized, multicenter, open-label phase III trial IMROZ, which found a statistically significant improvement in progression-free survival with isatuximab in combination with VRd. Isatuximab is a monoclonal antibody that binds to the CD38 receptor on MM cells, inducing apoptosis and immunomodulatory activities.
“Despite recent advancements in MM treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease,” said Dietmar Berger, MD, PhD, chief medical officer and global head of development at Sanofi. “The filing acceptances, as well as the FDA’s priority review designation, reinforce our confidence in [isatuximab] as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”
The treatment will continue to be evaluated in multiple ongoing phase III trials.
Source: Sanofi, May 27, 2024.
