The US Food and Drug Administration (FDA) accepted a new drug application (NDA) for iberdomide in combination with daratumumab (Darzalex) and dexamethasone for adult patients with relapsed or refractory multiple myeloma.
Iberdomide is the first in a new class of medicines called CELLMoD agents, which use targeted protein degradation to reach proteins previously considered undruggable. The FDA granted breakthrough therapy designation and priority review for the application, which has a target action date of August 17, 2026.
The filing was based on minimal residual disease negativity rates from the phase 3 EXCALIBER-RRMM study, where patients continue to be evaluated for progression-free survival. The review is being conducted under Project Orbis for concurrent international assessment, according to the press release by BMS,the manufacturer of the therapy.
