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
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