New drug application (NDA) for iberdomide has been accepted by the U.S. FDA
On Tuesday, February 17, the U.S. Food and Drug Administration accepted the new drug application (NDA) for iberdomide combined with standard treatment (daratumumab + dexamethasone) as treatment for relapsed/refractory multiple myeloma (RRMM).
According to a press release from Bristol Myers Squibb, “iberdomide is part of an investigational, new class of medicines called cereblon E3 ligase modulator (CELMoD) agents” and that “the FDA has granted a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026, for this indication.”
The application is based on results from a planned analysis of the Phase 3 EXCALIBER-RRMM clinical trial, which is evaluating iberdomide as treatment for people with RRMM.
The study compares a three-drug combination of iberdomide + daratumumab + dexamethasone (IberDd) with another three-drug regimen: daratumumab + bortezomib + dexamethasone (DVd).
The trial has two main goals (dual primary endpoints):
- Minimal residual disease (MRD) negativity, which measures how effectively treatment reduces cancer cells to very low or undetectable levels
- Progression-free survival (PFS), or how long patients live without their disease worsening
Additional outcomes being studied include overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), and health-related quality of life (HR-QoL).
The study was conducted in two stages:
- Stage 1: 1.0 mg was selected as the optimal dose of iberdomide based on safety, drug levels in the body (pharmacokinetics), and efficacy.
- Stage 2: approximately 664 patients were randomly assigned to receive either IberDd or DVd.
Based on these results, iberdomide was granted Breakthrough Therapy designation by the FDA — a status intended to speed up the development and review of promising treatments.
The EXCALIBER-RRMM study is still ongoing, and researchers continue to track progression-free survival (PFS).
The review is being conducted through the FDA’s Project Orbis program, which allows health authorities in several countries to review the application at the same time.
References:
U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma, Bristol Myers Squibb press release, February 17, 2026.
Project Orbis: A framework for concurrent submission and review of oncology products. U.S. Food and Drug Administration, Oncology Center of Excellence.