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Myeloma, Multiple Myeloma Treatments 

Aygün Sahin, MSc, PhD  | CEO and Cancer Lead, Cancer Education and Research Institute (CERI)

FDA approved treatments for Myeloma, Multiple Myeloma 

FDA approvals in 2021 
  • February 26, 2021: FDA granted accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
​The Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have 1) received at least four prior lines of therapy and 2) whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody. 
​Efficacy was evaluated in HORIZON (NCT02963493), a multicenter, single-arm trial.
FDA approvals in 2020 
  • August 5, 2020: FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma
​The Food and Drug Administration (FDA) 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.
  • March 2, 2020: FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma
I​f you are a multiple myeloma patient and have received at least 2 prior treatments, this might be good news for you! Talk to your doctor. 
​The Food and Drug Administration (FDA) approved isatuximab-irfc (SARCLISA, sanofi-aventis) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. 
#multiplemyeloma #myeloma #fdaapproved #fda #fdaapproval #today #isatuximab #isatuximabirfc #pomalidomide #dexamethasone #lenalidomide #proteasome ​#proteasomeinhibitor #sanofi #sanofiaventis
Resources: 
  1. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-melphalan-flufenamide-relapsed-or-refractory-multiple-myeloma (accessed on March 1, 2021)
  2. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma (accessed on March 1, 2021)
  3. https://www.fda.gov/drugs/development-approval-process-drugs/fda-approves-isatuximab-irfc-multiple-myeloma (accessed on March 2, 2020)

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