GSK's BCMA ADC Belantamab Mafodotin Receives FDA Approval as First-in-Class Therapy for Relapsed/Refractory Multiple Myeloma

Local time on October 23, GSK（GSK）Announcement: BCMA ADCMaBlinatumomab（Belantamab mafodotin ）Has been approved for marketing by the U.S. FDA, with indications forMaBlinatumomab+Bortezomib + DexamethasoneUsed for treatmentRecurrent/RefractoryMultiple Myeloma（MM）Adult patients，These patients had previously received at least two therapies, including proteasome inhibitors. (PI) And immunomodulators(IMID) Medicine. This is alsoThe world's first approved BCMA ADC.

This approval is based on the Phase III clinical trial DREAMM-7 (NCT04246047)The result of the study aimsIn assessmentMaBlinatumomab+Bortezomib+Dexamethasonevs Daratumumab +Bortezomib + DexamethasoneEfficacy and safety in treating patients with relapsed/refractory multiple myeloma, with PFS as the primary endpoint.

Data show that: patients who have received two or more prior treatment regimens (3L+)In patients,MaBlinatumomabCombination TherapyReduce the risk of patient death by 51%(HR 0.49, 95% Confidence Interval (CI): 0.32-0.76)，Median Progression-Free Survival (PFS) Extended to 31.3 Months （95% CI：23.5-NR）, while the median PFS in the daratumumab triplet therapy group was 10.4 months.（95% CI：7.0-13.4， HR 0.31，95% CI：0.21-0.47）。MaBlinatumomabThe safety and tolerability of the combination therapy are generally consistent with the known characteristics of each drug.

Although the first market launch failed, butMaBlinatumomab inFollow-up StudiesDREAMM-7 in China，Showed positive effects and finally received FDA approval for marketing again.。