Bristol’s son of Revlimid tests new FDA flexibility

Years after inheriting from Celgene a pipeline of follow-on “celmod” molecules Bristol Myers Squibb has put the first of these, iberdomide, in front of the US FDA. The regulator has accepted a filing for relapsed/refractory multiple myeloma with priority review, Bristol said on Tuesday, setting a 17 August PDUFA date. The move is notable not only because it positions iberdomide, a degrader of Ikaros and Aiolos, as a possible replacement for the now off-patent Revlimid, but also because it will test the FDA’s recently highlighted flexibility as regards multiple myeloma study endpoints. That’s because the trial supporting iberdomide’s filing, Excaliber-RRMM, has been toplined as positive only for MRD negativity, with PFS data as yet immature. Excaliber-RRMM combined iberdomide with Darzalex and dexamethasone, and concerned second or third-line use; given this setting Bristol was unsure whether MRD negativity alone would suffice, but recent FDA guidance has backed this endpoint in relatively early lines of therapy, and in accepting the iberdomide filing the agency has made good on its promise. Others now testing the FDA’s flexibility on MRD negativity include AstraZeneca with AZD0120 and Regeneron with Lynozyfic. Beyond being toplined, no actual data for Excaliber-RRMM have been published.