The FDA has expanded the label for Johnson & Johnson's monoclonal antibody Imaavy to include warm autoimmune hemolytic anemia, a rare disorder that destroys red blood cells. The approval comes sixteen months after Imaavy's initial FDA approval.
Why it matters: First label expansion for Imaavy adds a new rare blood disorder indication.
The FDA has granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide), the first cleared CELMoD therapy, in combination with Johnson & Johnson's Darzalex and dexamethasone for adults with previously treated multiple myeloma. The approval rests on the phase 3 Excaliber-RRMM trial, where the regimen achieved an MRD-negative complete response rate of 41% versus 21% for Darzalex, Velcade and dexamethasone at a median follow-up of 16 months. BMS must provide confirmatory PFS data expected this year, and its second CELMoD, mezigdomide, faces an FDA decision date of May 13, 2027.
Why it matters: First approval for a CELMoD drug and first new myeloma drug cleared directly on MRD as an endpoint.