FDA starts review of BMS's 'celmod' for multiple myeloma

Bristol Myers Squibb could be months away from bringing the first 'celmod' to market in the US, after the FDA kicked off a review of the company's iberdomide for relapsed or refractory multiple myeloma.

BMS is making a big wager on celmods – standing for cereblon E3 ligase modulators – and iberdomide is one of three in its late-stage pipeline of drug therapies for the haematological cancer, as it faces the loss of market exclusivity for current multiple myeloma blockbusters Revlimid (lenalidomide) and Pomalyst (pomalidomide).

The FDA has started a priority review of iberdomide as an add-on to Johnson & Johnson and Genmab's anti-CD38 antibody Darzalex (daratumumab) and dexamethasone, a standard regimen for relapsed or refractory multiple myeloma, and is due to deliver its decision by 17th August.

BMS's filing is based on the results of the EXCALIBER-RRMM study, which found a statistically significant improvement in minimal residual disease (MRD) negativity compared to the control arm of Darzalex, dexamethasone, and bortezomib, sold as Velcade by J&J and also available generically in the US. The trial is continuing to assess other endpoints, including progression-free survival (PFS) and overall survival (OS).

The company's chief medical officer, Cristian Massacesi, said the drug offers "a novel, potent, oral treatment option, with a manageable safety profile, for patients with multiple myeloma." It has been awarded breakthrough status by the FDA.

BMS's blood cancer franchise is already being hit by generic competition to Revlimid and Pomalyst, sales of which were halved last year to $2.35 billion and fell 23% to $2.34 billion, respectively, having earned $13 billion and $3.5 billion at their peak. Analyst forecasts for iberdomide's peak sales range from a little over $1 billion to $5 billion.

Meanwhile, BMS's other celmods – golcadomide for lymphoma and mezigdomide for multiple myeloma – are in late-stage clinical testing. All three of the celmods, which act as targeted protein degraders (TPDs), were acquired as part of the group's $74 billion merger with Celgene in 2019.

Mezigdomide was highlighted in IQVIA's new drugs to watch in 2026 report, which said that, if two phase 3 trials of the drug as a second-line therapy for multiple myeloma (SUCCESSOR-1 and SUCCESSOR-2) are positive, sales could each almost $1.5 billion in 2031.

One potential rival to BMS in the celmod category is C4 Therapeutics, whose cemsidomide is due to start the phase 2 MOMENTUM trial in relapsed/refractory multiple myeloma imminently, while other candidates are in early-stage development at Nurix (zelebrudomide), and Gluetacs (GT919 and GT929).