Bristol Myers Squibb Secures FDA Approval for ZENBEXUS in Multiple Myeloma

Bristol Myers Squibb (BMS) has received US Food and Drug Administration (FDA) approval for ZENBEXUS™ (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd).

For adults with multiple myeloma who have received at least one previous treatment line, including a proteasome inhibitor and an immunomodulatory agent. Continued approval will depend on confirmation of clinical benefit in ongoing trials.

ZENBEXUS is the first FDA-approved cereblon E3 ligase modulator (CELMoD), representing a new class of targeted protein degraders for multiple myeloma. 

The decision was supported by the Phase III EXCALIBER-RRMM trial, which evaluated ZDd against daratumumab, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.

At a median follow-up of 16 months, 41% of patients treated with ZDd achieved minimal residual disease (MRD)-negative complete response, compared with 21% in the comparator group. 

The result was statistically significant, supporting MRD negativity as a key measure of treatment response.

The ZDd safety profile was consistent with the treatment combination. 

Frequently reported adverse events included neutropenia and infections, while serious reactions included pneumonia, febrile neutropenia and sepsis.

The FDA review was conducted under Project Orbis. The approval expands BMS's multiple myeloma portfolio and strengthens its development of CELMoD-based therapies.