The U.S. Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) BLENREP (belantamab mafodotin-blmf) on October 23, 2025, for the treatment of adult patients with relapsed or refractory multiple myeloma. The approval allows the use of BLENREP in combination with Bortezomib and Dexamethasone (BVd) for patients who have received at least two prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent.
BLENREP is an antibody-drug conjugate (ADC) that targets B-cell maturation antigen (BCMA), a protein highly expressed on malignant plasma cells. The antibody component is an afucosylated IgG1 that binds selectively to BCMA, while its cytotoxic payload, mcMMAF, a microtubule inhibitor induces cancer cell death through microtubule disruption, apoptosis and antibody-dependent cellular cytotoxicity (ADCC).
The recommended dose is 2.5 mg/kg of actual body weight every three weeks, administered as a 30-minute intravenous infusion. It is given with BVd for the first eight cycles and then continued as a single agent until disease progression or unacceptable toxicity. The FDA’s decision was supported by strong late-phase clinical trial data demonstrating significant improvements in progression-free survival and overall response rates among heavily pretreated multiple myeloma patients.
Blood cancers such as multiple myeloma remain among the most difficult-to-treat malignancies and this approval provides a valuable new option for patients facing limited choices.
The approval of BLENREP marks a major advancement in hematologic oncology, expanding access to BCMA-directed therapies and reinforcing the promise of antibody-drug conjugate technology which merges targeted precision with potent cytotoxic action. This milestone could reshape current treatment strategies in multiple myeloma and spark further research into ADC-based therapies.
It also revives GSK’s presence in the field after the previous U.S. withdrawal of BLENREP, positioning the company once again at the forefront of innovation in blood cancer therapeutics.
Disclaimer: This article is intended for informational and educational purposes only. It does not constitute medical advice or replace consultation with qualified healthcare professionals. Patients should always seek guidance from their oncologist or healthcare provider regarding diagnosis, treatment options and medication use.
