The application is supported by data from the Phase 3 SUCCESSOR-2 trial, which demonstrated that the combination therapy significantly improved progression-free survival.
The trial indicated a 52 percent reduction in the risk of disease progression or death compared to the existing treatment of carfilzomib and dexamethasone alone.
The FDA has set a Prescription Drug User Fee Act date of May 13, 2027, for this application. Mezigdomide is an oral cereblon E3 ligase modulator, part of Bristol Myers Squibb’s targeted protein degradation programs.
“The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programs, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb.
