The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb and Bluebird Bio‘s application requesting the approval of idecabtagene vicleucel (ide-cel) for the treatment of adults with multiple ... Read more

The U.S. Food and Drug Administration has granted fast track designation to PBCAR269A, Precision BioSciences‘ donor-derived CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. Fast track status ... Read more

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kleo Pharmaceuticals‘ KP1237, an investigational treatment for multiple myeloma. The designation grants various development incentives to medications ... Read more

A Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma has been placed on hold by the U.S. Food and Drug ... Read more

The U.S. Food and Drug Administration (FDA) has granted priority review to Oncopeptide’s application seeking accelerated approval of melflufen (melphalan flufenamide) plus dexamethasone for people with relapsed or refractory multiple myeloma (RRMM). The new drug application ... Read more

Legend Biotech and Janssen’s investigational CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel) has been given breakthrough therapy designation in China as a potential treatment of relapsed or refractory multiple myeloma. Cilta-cel ... Read more

The European Commission (EC) has approved Blenrep (belantamab mafodotin), a first-in-class therapy developed by GlaxoSmithKline (GSK) for the treatment of multiple myeloma. The approval covers Blenrep as a monotherapy  — that ... Read more

The U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab), in combination with Kyprolis (carfilzomib) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma after one to three lines of therapy. Specifically, Darzalex — ... Read more

Darzalex Faspro (daratumumab and hyaluronidase) significantly extended the time people with relapsed or refractory multiple myeloma live without disease worsening, when added to a combination of Pomalyst (pomalidomide) and dexamethasone, ... Read more

Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. ... Read more

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Blenrep (belantamab mafodotin-blmf), a first-in-class treatment for heavily pretreated adults with relapsed or refractory multiple myeloma, its developer, GlaxoSmithKline, ... Read more

The U.S. Food and Drug Administration (FDA) has given Celyad Oncology permission to begin a Phase 1 clinical trial of CYAD-211, an investigational treatment for relapsed or refractory multiple myeloma. ... Read more