The U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to Bristol Myers Squibb & Co.’s (NYSE:BMY) Zenbexus (iberdomide) for adult patients with multiple myeloma.
The approval is for use in combination with daratumumab, hyaluronidase-fihj, and dexamethasone (ZDd) for patients who have undergone at least one prior therapy line, including a proteasome inhibitor and an immunomodulatory agent.
This makes Zenbexus the first FDA-approved CELMoD, a novel class of cereblon-modulating protein degraders.
FDA Approval Backed By EXCALIBER-RRMM Trial Data
The FDA’s decision is anchored in the results of the Phase 3 EXCALIBER-RRMM trial.
The study compared ZENBEXUS, daratumumab, and hyaluronidase-fihj, and dexamethasone (ZDd) against daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM).
After a median follow-up of 16 months, the ZDd combination showed a statistically significant improvement.
Specifically, 41% of patients achieved a minimal residual disease (MRD)-negative complete response (CR) compared to 21% treated with DVd. MRD-negativity is a critical indicator of response depth and predicts improved progression-free survival (PFS).
Notably, this is the first approval in RRMM based on MRD-negative CR.
Breakthrough Therapy Designation And Future Prospects
ZENBEXUS received a Breakthrough Therapy designation and was granted accelerated approval based on its performance in the EXCALIBER-RRMM study.
The review was conducted under the FDA’s Project Orbis, which facilitated concurrent evaluations by health authorities in multiple countries.
Full approval remains contingent on the verification of clinical benefits in confirmatory trials.
Bristol Myers Squibb also has a New Drug Application under review for another investigational CELMoD, mezigdomide, combined with carfilzomib and dexamethasone.
The FDA has set a Prescription Drug User Fee Act target date of May 13, 2027, for this review.
William Blair wrote that Zenbexus is priced at roughly $29,500 per 28-day cycle, which is above previous pricing assumptions.
Analyst Matt Phipps updated its model following FDA approval and currently forecasts U.S. Zenbexus sales to surpass $1 billion annually in early 2031.
BMY Stock Price Activity: Bristol-Myers Squibb shares were down 1.36% at $63.77 at the time of publication on Friday,
according to Benzinga Pro data.
Image via Shutterstock
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