Shots:
- FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent
- Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd; n=213) pts with r/r MM, which showed improvement across one of the dual 1EP of MRD-negative CR in 41% pts vs 21% at an mFU of 16mos.
- Additionally, an NDA for mezigdomide, a CELMoD, combined with carfilzomib & dexamethasone, is under FDA review, with a PDUFA target date of May 13, 2027
Ref: Businesswire | Image: BMS | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
