Bristol Myers Squibb’s Iberdomide NDA Accepted By FDA For Relapsed Or Refractory Multiple Myeloma, FDA Grants Breakthrough Therapy Designation To Iberdomide

Bristol Myers Squibb has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for iberdomide in combination with daratumumab and dexamethasone (IberDd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

Iberdomide belongs to an investigational class of therapies known as cereblon E3 ligase modulators (CELMoD agents), designed to enhance the immune system’s ability to target malignant cells. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 17, 2026, for this indication.

“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 NDA submission is supported by findings from a planned analysis of measurable residual disease (MRD) negativity rates in the Phase 3 EXCALIBER-RRMM study, which is evaluating iberdomide in patients with RRMM. The trial continues, with patients monitored for progression-free survival (PFS).

In addition, the FDA has granted Breakthrough Therapy designation to iberdomide based on the submitted data, reflecting its potential to offer substantial improvement over existing treatment options. The application is being reviewed under the FDA’s Project Orbis, an initiative that facilitates concurrent regulatory review among international health authorities. Bristol Myers Squibb acknowledged the contributions of patients and investigators participating in the Phase 3 EXCALIBER study.