GSK’s Blenrep (belantamab mafodotin-blmf) Receives the US FDA’s Approval as a Monotherapy Treatment for Multiple Myeloma
GSK and Innoviva’s Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA’s Approval for Asthma and COPD
Shots:
- The approval is based on a pivotal study, DREAMM-2 assessing Blenrep (2.5 mg/kg, q3w) in 218 patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite current SoC
- Results: Blenrep demonstrated an ORR (31%), DoR not reached at the 6-mos. analysis, but 73% of responders had a DoR ≥ 6 mos. Continued approval for this indication depends upon verification and description of clinical benefit in confirmatory trials
- Blenrep (belantamab mafodotin-blmf) is an antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F. Blenrep is the 1st anti-BCMA therapy approved globally and 5th major medicine approval for GSK in 2020
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