The FDA has accepted Bristol Myers Squibb (BMS)’s New Drug Application (NDA) for iberdomide for relapsed or refractory multiple myeloma.

The indication is granted for iberdomide combined with standard treatment (daratumumab + dexamethasone – IberDd). The Prescription Drug User Fee Act date is Aug. 17, 2026.

Other FDA Actions on Iberdomide

According to data currently received, the FDA has additionally granted Breakthrough Therapy designation for iberdomide in this indication.

Also of note, the FDA’s Project Orbis initiative is conducting the review. Concurrently, the FDA can conduct this review along with others by health authorities in other countries.

Impact on Multiple Myeloma Patients

Cristian Massacesi, BMS Executive Vice President and Chief Medical Officer, said the FDA’s approval of the NDA is a “testament to the potential of iberdomide.”

To further define iberdomide, it is in an investigational new class of medicines, cereblon E3 ligase modulator (CELMoD) agents.

Massacesi said in conjunction with anti-CD38 monoclonal antibodies, iberdomide is a “potent oral treatment option with a manageable safety profile.”

“Our filing for iberdomide … underscores our commitment to pioneering new ways of advancing life-saving therapies,” Massacesi said.

The filing, as BMS explained, was based on results from a Phase III study evaluating iberdomide in multiple myeloma patients.

That trial is still ongoing, with patients being evaluated for progression-free survival.

BMS Reports Q4 Data

Also recently, BMS released Q4 2025 results. Growth Portfolio revenues were $7.4 billion, up 16% primarily driven by the immuno-oncology portfolio, Camzyos, Breyanzi and Reblozyl.

Earnings for the quarter and year reflected the impact of Acquired IPRD charges of $1.4 billion and $3.7 billion, respectively. For the most part, these were driven by BMS’ acquisition of Orbital Therapeutics.

Legacy Portfolio revenues were $5.1 billion, down 15%.