UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin). GSK is seeking approval for the drug in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy.
Blenrep: An Antibody Drug Conjugate for Targeted Cancer Therapy
Blenrep is an innovative antibody drug conjugate (ADC) that targets the B-cell maturation antigen (BCMA) and is conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The development of the drug involves licensing technology from Seagen Inc., and Kyowa Kirin Group. Initially conditionally approved in the US and EU in 2020 as a monotherapy treatment for relapsed/refractory multiple myeloma (r/r MM) in the fourth-line setting, Blenrep faced challenges when it began to be withdrawn from both markets in 2022 following the DREAMM-3 study’s failure to confirm its benefit.
Ongoing Global Development for Combination Regimens
Despite the setbacks, global development for Blenrep as part of combination regimens continues. The FDA’s review of the BLA for these new combinations could potentially expand treatment options for patients with multiple myeloma, offering a new approach to managing this complex disease.-Fineline Info & Tech
