• FDA Announcements

FDA Approved for RRMM: Belantamab mafodotin-blmf

Updated: Oct 16, 2021



On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) 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, 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.

dexamethasone (Kd).


 

Learn more:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma


08/05/2020: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761158Orig1s000ltr.pdf


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