The US Food and Drug Administration has accepted a new drug application for mezigdomide in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
The decision was based on results from the phase 3 SUCCESSOR-2 trial that evaluated mezigdomide, an oral cereblon E3 ligase modulator, or CELMoD, in combination with carfilzomib and dexamethasone versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The trial details were published in The Lancet in June 2026.
CELMoDs are a new distinct drug class that have transformed myeloma, according to Paul G. Richardson, MD, a principal investigator on the SUCCESSOR-2 trial.
“I think it’s important for our audience to understand that they are quite distinct as a class from the original IMiDs, which have transformed myeloma management over the last three decades,” he said in a roundtable discussion on the topic.
The FDA has a set a target decision date of May 13, 2027 for this indication, according to the therapy’s manufacturer Bristol-Myers Squibb.
Watch our roundtable series on the trial and mezigdomide.
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