FDA Approves Bristol Myers Squibb's ZENBEXUS for Multiple Myeloma

The FDA granted accelerated approval on August 13 to Bristol Myers Squibb's BMY ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj plus dexamethasone, a regimen the company abbreviates ZDd. The indication is relapsed or refractory multiple myeloma in adults who have had at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, which places the regimen as early as first relapse rather than in the newly diagnosed, first-line setting.

This is the first approval for a CELMoD, Bristol Myers Squibb's class of cereblon-modulating protein degraders, and the class matters more than the single label. The company has been building the CELMoD franchise as the successor to Revlimid and Pomalyst economics, and a first clearance validates the mechanism ahead of trials running in earlier lines.

The approval rests on the phase 3 EXCALIBER-RRMM trial, which showed a 41% MRD-negative complete response rate for ZDd against 21% in the control arm at roughly 16 months median follow-up. Because this is accelerated approval, continued marketing depends on confirmatory evidence.

Shares closed at $64.66 on August 13, up 1.50%, a muted move that reflects how far out the revenue sits. Sell-side peak-sales estimates span roughly $1 billion to $5 billion, an unusually wide range that captures the real uncertainty: how much share ZDd takes in a crowded relapsed myeloma market against bispecifics and cell therapies from JNJ and others. What to watch is label expansion into earlier lines and the confirmatory readout.