Ide-cel Granted FDA Priority Review for Heavily-treated Multiple Myeloma
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…
Myeloma
FDA Grants Fast Track Designation to ‘Off-the-shelf’ CAR T-cell Therapy
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…
Investigational Myeloma Treatment KP1237 Wins FDA Orphan Drug Status
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kleo Pharmaceuticals‘ KP1237, an investigational treatment for…
FDA Puts on Hold Phase 1 Cellectis Trial Testing CAR T-cell Therapy UCARTCS1A
A Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma has…
LLS Highlights Its Support Programs During Blood Cancer Awareness Month
Throughout September for Blood Cancer Awareness Month, the Leukemia & Lymphoma Society (LLS) is asking the public to join its commitment to research, education, advocacy,…
Melflufen Combo Earns FDA Priority Review for Triple-refractory Myeloma
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…
Trial Begins Dosing of ‘Off-the-shelf’ CAR T-cell Therapy for Multiple Myeloma
The first patient has been dosed in a Phase 1/2a trial investigating Precision BioSciences‘ new CAR T-cell therapy candidate, PBCAR269A, for people with relapsed…
Cilta-cel, CAR T-cell Treatment, Named Breakthrough Therapy in China
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…
First-in-class Blenrep Approved by European Commission for Myeloma
The European Commission (EC) has approved Blenrep (belantamab mafodotin), a first-in-class therapy developed by GlaxoSmithKline (GSK) for the treatment of multiple myeloma.
FDA Approves Darzalex Triple Combo for Advanced Multiple Myeloma
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…
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