Bristol-Myers Squibb Says US FDA Accepts New Drug Application for Mezigdomide Combination Therapy in Myeloma

Bristol-Myers Squibb (BMY) said Monday the US Food and Drug Administration has accepted a new drug application for mezigdomide, in combination with carfilzomib and dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma. The filing was based on a phase 3 study that demonstrated the combination therapy's "meaningful and statistically significant" improvement in progression-free survival, the drugmaker said. The FDA has assigned a target action date of May 13, 2027, for the combination therapy, the company said.