FDA Grants Priority Review to Iberdomide for Relapsed or Refractory Multiple Myeloma
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for iberdomide in combination with daratumumab and dexamethasone (IberDd) in patients with relapsed or refractory multiple myeloma (RRMM). A Prescription Drug User Fee Act target date of August 17, 2026 has been set for the application.
The NDA is supported by data from the 2-stage, randomized, open-label EXCALIBER-RRMM trial (ClinicalTrials.gov Identifier: NCT04975997), which evaluated the safety and efficacy of iberdomide, an investigational cereblon E3 ligase modulator, alongside daratumumab and dexamethasone in adults with RRMM.
In stage 1, approximately 200 participants were randomly assigned to receive iberdomide (1mg, 1.3mg, or 1.6mg) alongside daratumumab and dexamethasone or daratumumab, bortezomib, and dexamethasone (DVd). Findings showed iberdomide 1mg was the optimal dose based on safety, pharmacokinetics, and efficacy data.
In stage 2, approximately 664 participants were randomly assigned 1:1 to receive optimal dose IberDd or DVd until confirmed progressive disease, unacceptable toxicity or withdrawal of consent. The coprimary endpoints were progression-free survival (PFS) and minimal residual disease (MRD) negative complete response at any time.
Findings from a planned interim analysis showed that IberDd significantly improved MRD negativity rates vs DVd. Evaluation of PFS is ongoing while the data matures.
The executive vice president and chief medical officer at Bristol Myers Squibb stated that the FDA's acceptance of this application is a testament to the potential of iberdomide. The filing for iberdomide based on the MRD endpoint underscores the company's commitment to pioneering new ways of advancing life-saving therapies for patients living with cancer.