FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales

The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in combination with dexamethasone and Johnson & Johnson’s Darzalex.

The approval is conditional; Bristol Myers Squibb must demonstrate clinical benefit in a late‑stage confirmatory study to retain full approval.

Zenbexus is priced at $29,500 for a 28‑day cycle, higher than analysts had expected, and the company forecasts the product could generate more than $1 billion in annual earnings by 2031.

The launch comes as sales of BMS’s existing myeloma drugs have slumped, with Revlimid down 49% year‑on‑year to $425 million and Pomalyst falling 71% in the second quarter, reflecting pressure from generic competitors.