BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Shots: The US FDA has accepted NDA & granted priority review to mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027) NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd at 1mg of mezigdomide (dose selected in stage 1, n=288) or kd (n=191) Trial showed improved PFS (1EP), with a 52% reduction in the risk of disease progression or death in r/r MM pts, incl. those at first relapse after prior treatment with an anti-CD38 monoclonal antibody & lenalidomide; data published in The Lancet   Ref: Businesswire   |   Image:  BMS   | Press Release Related News: BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma appeared first on PharmaShots.