GSK Announces FDA Accelerated Approval of Blenrep (belantamab mafodotin-blmf), the First Anti-BCMA Antibody-Drug Conjugate, for Relapsed or Refractory Multiple Myeloma

Reposted from | Jike Yaowen

On August 6, GlaxoSmithKline (GSK) announced that the U.S. FDA had approved Blenrep (belantamab mafodotin-blmf) as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. This indication was granted accelerated approval based on response rate. Blenrep is the first approved anti-BCMA (B-cell maturation antigen) therapy worldwide.

The approval of Blenrep was based on the 6-month preliminary results of the DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma whose disease progressed despite standard therapy. In the study, among patients (n=97) who had received a median of 7 prior lines of therapy, the overall response rate (ORR) for Blenrep was 31% (97.5% CI: 21–43). At the time of the 6-month analysis, the median duration of response (DoR) had not been reached, and 73% of responders had a DoR of ≥6 months.

Dr. Hal Barron, GSK’s Chief Scientific Officer and President of Research and Development, stated, “Multiple myeloma, the second most common blood cancer in the United States, is an incurable disease. Blenrep is the first approved anti-BCMA therapy and has the potential to transform treatment for patients with relapsed or refractory multiple myeloma who currently have limited therapeutic options.” Blenrep is the fifth blockbuster drug approved for GSK in 2020, addressing areas of significant unmet medical need, including cancer, HIV, and chronic kidney disease. This approval marks the second FDA approval for GSK’s oncology portfolio within four months.

▲ Mechanism of Action of BCMA-Targeted ADCs (Image source: Reference [2])

Blenrep is an antibody-drug conjugate composed of a humanized anti-B-cell maturation antigen (BCMA) monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. In 2017, Blenrep received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). At the end of 2019, GSK submitted a Biologics License Application (BLA) for the drug to the FDA, which subsequently granted it Priority Review status. On July 14 this year, GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in support of the candidate drug, concluding that its benefits outweigh its risks for the treatment of patients with relapsed/refractory multiple myeloma. Notably, the product received implicit approval for clinical trials in China in May this year, with the indication being: in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

References:

[1] https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-blenrep-belantamab-mafodotin-blmf-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/

[2]Shah, N., Chari, A., Scott, E. et al. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches. Leukemia 34, 985–1005 (2020)

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