GlaxoSmithKline plc (GSK.L,GSK) announced Thursday that the US Food and Drug Administration has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma.
BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
The company noted that the latest approval is for treating patients with relapsed or refractory multiple myeloma who have received at least four prior therapies. Multiple myeloma is the second most common form of blood cancer in the US.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Sagar Lonial, Principal Investigator for DREAMM-2, said, “While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care. Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of BLENREP, the first anti-BCMA therapy, is significant for both patients and physicians alike.”
BLENREP is GSK’s fifth major medicine approval in 2020. It is the second FDA approval for GSK’s oncology portfolio in four months.
In 2017, BLENREP was granted Breakthrough Therapy designation by the FDA.
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