Recent FDA approvals, decisions in multiple myeloma
The FDA has made several notable approvals and decisions on treatment for multiple myeloma in the past year. To highlight new and emerging therapies, Healio compiled a list of these potentially practice-changing FDA actions.
FDA approves Sarclisa regimen for adults with advanced multiple myeloma
The FDA approved isatuximab-irfc in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who received at least two previous therapies, including lenalidomide and a proteasome inhibitor. Read more.
FDA approval allows for subcutaneous dosing of daratumumab for myeloma
The FDA approved daratumumab and hyaluronidase-fihj for adults with newly diagnosed or relapsed/refractory multiple myeloma. Read more.
FDA panel supports approval of belantamab mafodotin for relapsed/refractory myeloma
An FDA advisory committee today voted unanimously to recommend approval of belantamab mafodotin for patients with relapsed or refractory multiple myeloma, concluding the clinical benefits outweigh potential risks that include keratopathy. Read more.
FDA clears IND application for off-the-shelf, BCMA-directed CAR-T for advanced myeloma
The FDA cleared an investigational new drug application for CYAD-211, a chimeric antigen receptor T-cell therapy for the treatment of relapsed or refractory multiple myeloma, according to a press release from the agent’s manufacturer. Read more.
FDA approves Blenrep for relapsed, refractory multiple myeloma
The FDA granted accelerated approval to belantamab mafodotin-blmf for treatment of relapsed or refractory multiple myeloma. Read more.
FDA approves Darzalex-based regimen for relapsed, refractory multiple myeloma
The FDA approved daratumumab combined with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, according to a press release. Read more.
FDA grants priority review to melflufen for refractory multiple myeloma
The FDA granted priority review to melflufen in combination with dexamethasone for the treatment of adults with triple-class refractory multiple myeloma, according to a manufacturer-issued press release. Read more.
FDA grants priority review to idecabtagene vicleucel for advanced multiple myeloma
The FDA granted priority review to idecabtagene vicleucel for the treatment of certain adults with relapsed or refractory multiple myeloma, according to the agent’s developers. Read more.
FDA approves Xpovio as part of combination for pretreated multiple myeloma
The FDA approved selinexor as part of a three-agent regimen for adults with multiple myeloma who received at least one prior therapy. Read more.
FDA approves Pepaxto for relapsed multiple myeloma
The FDA granted accelerated approval to melphalan flufenamide in combination with dexamethasone for treatment of certain patients with relapsed or refractory multiple myeloma. Read more.
