GlaxoSmithKline's filing for belantamab mafodotin in multiple myeloma nabs FDA priority review

The FDA granted priority review to GlaxoSmithKline's marketing application seeking approval of belantamab mafodotin for heavily pre-treated patients with relapsed or refractory multiple myeloma, the company reported Tuesday. GlaxoSmithKline noted that the immunoconjugate, also known as GSK2857916, has the potential to be the first anti-BCMA treatment available to patients.

According to the drugmaker, the filing is based on data from the pivotal DREAMM-2 study, which enrolled 196 patients who had actively progressing multiple myeloma that had worsened despite prior therapy that included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Results published last month in The Lancet Oncology showed that the lower dose of belantamab mafodotin was associated with an overall response rate (ORR) of 31%, while the ORR in the higher-dose group was 34%.

However, the DREAMM-2 trial also showed that Grade 3 or 4 adverse events such as keratopathy, thrombocytopenia and anaemia occurred at rates that ranged from 20% to 40%, with two deaths potentially associated with the treatment.

Last month, Johnson & Johnson presented data at the American Society of Hematology (ASH) annual meeting from a Phase Ib/II study of JNJ-68284528, with the experimental BCMA-directed CAR-T therapy showing a 100% response rate in patients with relapsed or refractory multiple myeloma. Regeneron Pharmaceuticals also detailed initial clinical findings at the conference for REGN5458, an experimental bispecific antibody targeting both BCMA and CD3, with responses observed in 57% of patients with relapsed or refractory multiple myeloma.

For related analysis, see ViewPoints: Race to market? GlaxoSmithKline focused on race to awareness with anti-BCMA ADC, and KOL Views Results: Leading haematologist impressed by anti-BCMA bispecifics but says speed is of the essence

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