Nicholas Richardson, Vice President Clinical Development at Precision For Medicine, shared on LinkedIn:
“Congratulations to Bristol Myers Squibb and the multiple myeloma community on the FDA‘s accelerated approval of iberdomide in combination with daratumumab, 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.
The approval was supported by the Phase 3 EXCALIBER-RRMM study, where the major efficacy endpoint was MRD-negative complete response.
The MRD-negative CR rate was 41% with the iberdomide combination compared with 21% for the comparator arm.
Beyond adding another treatment option for patients with relapsed or refractory multiple myeloma, this approval is notable for the role MRD played in the regulatory decision.
I’ll be sharing more thoughts on this approval later this week, including what it represents for the multiple myeloma community and the evolution of MRD in regulatory decision-making.
Learn more here.”
You can also read: FDA Grants Accelerated Approval to Iberdomide Combination for Multiple Myeloma Based on MRD-Negative CR
