FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

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The Food and Drug Administration (FDA) approved belantamab mafodotin-blmf for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Belantamab mafodotin-blmf was evaluated in DREAMM-2 (NCT 03525678), an open-label, multi-centre trial.

Patients received either belantamab mafodotin-blmf, 2.5 mg/kg or 3.4 mg/kg intravenously, once every 3 weeks until disease progression or unacceptable toxicity.

Efficacy was based on overall response rate (ORR) and response duration, as evaluated by an independent review committee using the International Myeloma Working Group uniform response criteria.

The ORR was 31% (97.5% CI: 21%, 43%).

Seventy-three percent of responders had response durations ≥6 months.

These results were observed in patients receiving the recommended dose of 2.5 mg/kg.

The prescribing information includes a Boxed Warning stating belantamab mafodotin-blmf causes changes in the corneal epithelium resulting in alterations in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes.

Ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms should be conducted.

Because of the risks of ocular toxicity, belantamab mafodotin-blmf is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the BLENREP REMS.

Adverse reactions in ≥20% patients who received belantamab mafodotin-blmf were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.

The recommended belantamab mafodotin-blmf dose is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks.

View full prescribing information for belantamab mafodotin-blmf here.


Source: The Food and Drug Administration (FDA)

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The ONA Editor curates oncology news, views and reviews from Australia and around the world for our readers. In aggregated content, original sources will be acknowledged in the article footer.

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