FDA Grants Accelerated Approval to Belantamab Mafodotin-Blmf for Multiple Myeloma
On August 5, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma) to belantamab mafodotin-blmf (Blenrep) for adult patients with relapsed or refractory multiple myeloma who received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Belantamab mafodotin-blmf was evaluated in an open-label, multicenter trial (DREAMM-2; NCT 03525678) in which patients received either belantamab mafodotin-blmf, 2.5 mg/kg or 3.4 mg/kg via IV, once every three weeks until they experienced 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. ORR was 31% (97.5% CI = 21%, 43%). Seventy-three percent of responders had response durations of at least six months. These results were observed in patients receiving the recommended dose of 2.5 mg/kg.
The prescribing information includes a boxed warning stating that belantamab mafodotin-blmf causes changes in the corneal epithelium resulting in alterations in vision, including severe vision loss and corneal ulcer; blurred vision; and dry eyes. Ophthalmic exams should be conducted at baseline, prior to each dose, and promptly for worsening symptoms.
Because of the risks of ocular toxicity, belantamab mafodotin-blmf is available only through a restricted program under a risk evaluation and mitigation strategy (REMS), called the Blenrep REMS.
Adverse reactions patients who received belantamab mafodotin-blmf (≥ 20%) experienced 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 IV infusion over approximately 30 minutes once every three weeks.
View full prescribing information for Blenrep (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf).
FDA gave the indication accelerated approval based on response rate. Continued approval for the indication may be contingent on verification and description of clinical benefit in confirmatory trials.
The review used the Real-Time Oncology Review (https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program), which streamlined data submission prior to the filing of the entire clinical application, and Assessment Aid (https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid), a voluntary submission from the applicant to facilitate FDA’s assessment.
FDA granted belantamab mafodotin-blmf orphan drug, breakthrough therapy, and priority review designations for this indication. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics).
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.
For assistance with single-patient oncology investigational new drug applications, contact the Oncology Center of Excellence’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).