Approval Sought for Belantamab Mafodotin Combos for R/R Multiple Myeloma in Japan

CAR-T Digest - August 2020

18 Sep 2024: Approval Sought for Belantamab Mafodotin Combos for R/R Multiple Myeloma in Japan

A new drug application for belantamab mafodotin (Blenrep) in combination with bortezomib or pomalidomide has been accepted for review in Japan, receiving orphan drug designation
The application is supported by findings from phase 3 studies DREAMM-7 and DREAMM-8, which showed a progression-free survival benefit compared to standard treatments
In DREAMM-7, the combination of belantamab mafodotin and bortezomib achieved a median progression-free survival of 36.6 months, significantly better than the control arm’s 13.4 months.
DREAMM-8 indicated a favorable outcome for belantamab mafodotin with pomalidomide, with median progression-free survival not reached compared to 12.7 months for the control group
A Japan expansion cohort will further investigate the efficacy of these treatments in Japanese patients, with data expected to be presented at a future scientific meeting