publication date: Jul. 17, 2020

ODAC votes Yes on advanced multiple myeloma agent with ocular toxicity

By Paul Goldberg

The FDA Oncologic Drugs Advisory Committee July 14 voted 12-0 to recommend approval for belantamab mafodotin for relapsed or refractory multiple myeloma.

The Biologics License Application for the GlaxoSmithKline agent went to ODAC because belantamab mafodotin is associated with adverse events not seen in any other treatment for multiple myeloma: ocular toxicity.

Belantamab mafodotin is a B-cell maturation antigen-directed antibody and microtubule inhibitor conjugate. GSK is seeking approval to use the drug as a monotherapy for the treatment of 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.

In a virtual meeting based on an Adobe platform and marred by crippling technical problems, ODAC reviewed data from GSK’s DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program, including the pivotal DREAMM-2 study. The six-month primary results from the study were previously published in The Lancet Oncology last December.

DREAMM-2 was an open-label, multicenter study evaluating two doses of belantamab mafodotin in patients with relapsed/refractory multiple myeloma (RRMM). Patients were randomized 1:1 to receive either 2.5 mg/kg or 3.4 mg/kg of belantamab mafodotin.

Patients in the DREAMM-2 trial were heavily pretreated, with 50% receiving seven or more lines of therapy. The overall response rate was 31%, as assessed by an Independent Review Committee in DREAMM-2 with the 2.5 mg/kg belantamab mafodotin dose. FDA agreed that the reported duration of response may be beneficial in this heavily pretreated population.

FDA frequently uses ODAC to discuss new molecular entities and novel … Continue reading ODAC votes Yes on advanced multiple myeloma agent with ocular toxicity

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