FDA grants accelerated approval to iberdomide combo in multiple myeloma

The US Food and Drug Administration has granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, according to Bristol Myers Squibb, the manufacturer of the drug.

In a press release, Bristol stated the approval is based on results from the phase 3 EXCALIBER-RRMM trial, which showed iberdomide significantly improved minimal residual disease-negative complete response rates.

Bristol reported that the FDA approval was the first based on MRD-negative CR in relapsed or refractory multiple myeloma.

“The FDA approval of iberdomide marks the anticipated arrival of a new therapeutic class for relapsed or refractory multiple myeloma and has the potential to make a meaningful difference for patients,” said Sagar Lonial, MD, FACP, FASCO, EXCALIBER-RRMM lead investigator and CMO of the Winship Cancer Institute of Emory University. “The strong results observed with the CELMoD-based combination within a familiar triplet approach creates the potential for a new treatment foundation in multiple myeloma.”