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Treats relapsed or refractory multiple myeloma. Sold as Blenrep. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Belantamab Mafodotin-Blmf (sold as Blenrep), first approved Oct 23, 2025, with 0 new uses approved and 1 published complete response letter.
First approved in Japan 5 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Blenrep, new ingredientA drug with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma. · GlaxoSmithKline K.K. · May 19, 2025 · Review report
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Blenrep REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Oct 23, 2025
Clinical Trials
4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
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