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Xagena Newsletter

FDA has granted accelerated approval to Blenrep for multiple myeloma

The Food and Drug Administration ( FDA ) has granted accelerated approval to Blenrep ( Belantamab mafodotin-blmf; Belantamab mafodotin ) 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, an open-label, multicenter 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% ). 73% of responders had response durations greater than or equal to 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% or more 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.

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. ( Xagena )

Fonte: FDA, 2020