By: IPP Bureau
Last updated : February 17, 2026 8:40 pm
Iberdomide has the potential to be the first approved CELMoD agent
The U.S. Food and Drug Administration (FDA) has accepted Bristol Myers Squibb's New Drug Application for iberdomide, an investigational cereblon E3 ligase modulator (CELMoD) agent, combined with daratumumab and dexamethasone (IberDd) for relapsed or refractory multiple myeloma. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026, for this application. Read the full announcement on the Bristol Myers Squibb website.
“The FDA’s acceptance of this application is a testament to the potential of iberdomide, in combination with anti-CD38 monoclonal antibodies, as a novel, potent, oral treatment option, with a manageable safety profile, for patients with multiple myeloma,” said Cristian Massacesi, executive vice president and chief medical officer, Bristol Myers Squibb. “Furthermore, our filing for iberdomide based on the MRD endpoint, underscores our commitment to pioneering new ways of advancing life-saving therapies for patients living with cancer.”
The filing was based on results from a planned analysis of MRD negativity rates in the Phase 3 EXCALIBER-RRMM study evaluating iberdomide as a treatment for RRMM patients. The EXCALIBER-RRMM trial is ongoing and patients continue to be evaluated for progression-free survival (PFS).
The FDA also granted Breakthrough Therapy designation for iberdomide based on these data.
This review is being conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries.