GlaxoSmithKline announced that the FDA granted accelerated approval to Blenrep (belantamab mafodotin-blmf) for the treatment of certain adults with relapsed or refractory multiple myeloma. The company noted that the antibody-drug conjugate is the first anti-BCMA therapy authorised anywhere in the world.
Specifically, Blenrep is indicated for adults 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. GlaxoSmithKline indicated that under a risk evaluation and mitigation strategy, all doctors prescribing Blenrep must be educated regarding the ocular risks associated with treatment as well as monitoring.
The approval of Blenrep comes less than a month after an FDA advisory panel voted 12 to 0 that the benefits of the therapy outweigh the risks for the proposed patient population with relapsed or refractory multiple myeloma. The positive vote came after agency staff questioned whether Blenrep's benefits exceed the potential risk of ocular toxicity seen in the pivotal DREAMM-2 trial. At the time, reviewers noted that keratopathy was the most common adverse event reported in the study, with an overall incidence of 71%, while 44% of patients experienced at least one episode of severe keratopathy at the 2.5 mg/kg dose.
More recently, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended granting conditional marketing approval of Blenrep (belantamab mafodotin) to treat adults with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Blenrep comprises a humanised anti-BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker based on technology licensed from Seattle Genetics.
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