The FDA approves Zenbexus just as copycat competitors depress sales of Bristol Myers Squibb’s multiple myeloma drugs Pomalyst and Revlimid, which crashed 71% and 49% year-on-year, respectively, in the second quarter.
The FDA has granted accelerated approval to Bristol Myers Squibb’s iberdomide for the treatment of multiple myeloma, giving the pharma the opportunity to regain its footing in the indication as generics erode current sales.
Iberdomide, now to carry the brand name Zenbexus, is indicated as part of a treatment regimen with dexamethasone and Johnson & Johnson’s Darzalex for patients who have undergone at least one prior line of treatment, according to a news release on Thursday. The drug carries a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism.
For full and continued approval, BMS will need to verify the clinical benefit of Zenbexus in a late-stage confirmatory study.
Zenbexus costs $29,500 for a 28-day cycle, higher than what analysts at William Blair had initially expected, according to a Friday morning note. The firm expects the drug to go over $1 billion in annual earnings by 2031.
The approval of Zenbexus comes amid declining sales of BMS’ other multiple myeloma drugs. Revlimid, first approved in 2005, crashed 49% year-on-year to make $425 million worldwide in the second quarter. Meanwhile, Pomalyst, generics for which entered the market earlier this year, plummeted 71% to $204 million worldwide in Q2.
BMS has been managing the erosion of these products well, however, clocking $12.97 billion in total revenue for the second quarter—a 5% year-on-year increase and a comfortable beat over the $11.73 billion consensus. The company has lifted 2026 sales guidance by 6% to $49.5 billion.
The FDA’s verdict on Thursday was supported by data from the Phase 3 EXCALIBER-RRMM study, which found that the Zenbexus-based regimen elicited a significantly higher rate of minimal residual disease (MRD)-negative complete response than standard of care. MRD negativity is considered a predictor of progression-free survival, BMS said.
Zenbexus is the first approval for BMS’s CELMoD platform, which makes use of cells’ innate trash disposal system to target and destroy abnormal proteins that would otherwise lead to cancer. Another CELMoD candidate called mezigdomide is also under FDA review for relapsed or refractory multiple myeloma, with a decision due next May.
BMS recently made headlines earlier this month when The Financial Times reported that the pharma was in talks with AstraZeneca for a potential mega-merger. Given their respective sizes and overlapping portfolios, many analysts dismissed the deal as “unlikely.” Indeed, just days later, an anonymous source with knowledge of the matter disavowed the rumor, telling Reuters that “there never was a deal to be done, and there are no discussions between the companies.”
