The P-III study (CARTITUDE-4) that evaluated the efficacy & safety of Carvykti vs pomalidomide, bortezomib & dexamethasone (PVd), or daratumumab, pomalidomide & dexamethasone (DPd) in patients with r/r MM who received one to three prior lines of therapy
The trial met its 1EPs i.e., improvement in PFS at the first pre-specified interim analysis. Based on the positive results, the IDMC recommended the unblinding of the P-III study & the results will be shared with health authorities
The therapy was approved in the US in Feb 2022 for r/r MM & received conditional marketing authorization from EC in May 2022. The therapy was also approved in Japan in Sept 2022 for the same indication
Ref: PRNewswire | Image: Janssen
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