The U.S. Food and Drug Administration (FDA) has granted priority review to Pfizer‘s application of its investigational under-the-skin therapy elranatamab for people with relapsed or refractory multiple myeloma. Priority review is given to therapies that target serious medical conditions that outperform current treatments to make them available to…
Janssen Pharmaceuticals is seeking European Union approval for talquetamab, a subcutaneous (under-the-skin) antibody therapy for hard-to-treat multiple myeloma. The request, in the form of a marketing authorization application to the European Medicines Agency (EMA), will be reviewed under accelerated assessment, which reduces the expected review period from…
A CAR T-cell therapy called CART-ddBCMA that targets the protein BCMA — produced at high levels in myeloma cells — safely led to lasting responses in relapsed and refractory multiple myeloma (RRMM) patients, a Phase 1 study showed. Given the small study size, further trials in larger groups…
Adding Ninlaro (ixazomib) to cyclophosphamide and dexamethasone does not improve progression-free survival for multiple myeloma patients who relapsed after several lines of treatment, a Phase 2 trial reported. The study, “Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomised controlled…
Carvykti (ciltacabtagene autoleucel; cilta-cel) has been recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), for eligible adults with relapsed and refractory multiple myeloma. The CAR T-cell therapy will be available for patients who have…
Black people with multiple myeloma live longer than white patients with similar disease symptoms when both receive the same new and updated medical treatments, according to an analysis of the Surveillance, Epidemiology, and End Results (SEER) database. However, Black myeloma patients were less likely to receive such novel treatments…
The therapy Sarclisa (isatuximab) extended survival by nearly seven months in relapsed/refractory multiple myeloma patients also given Pomalyst (pomalidomide) and dexamethasone as standard treatment, according to updated three-year data from the ICARIA-MM Phase 3 trial. The data, “Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide…
The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase), in combination with Kyprolis (carfilzomib) and the corticosteroid dexamethasone, for the treatment of adults with multiple myeloma who have received one to three lines of therapy. Darzalex Faspro is a subcutaneous, or under-the-skin, formulation…
People with blood type O are significantly less likely to develop multiple myeloma, but those who do are likely to have more aggressive disease and poorer survival outcomes, a study found. The study, “Effect of the…
Xgeva (denosumab) has been approved by the China National Medical Products Administration (NMPA) to prevent bone problems — such as fractures, spinal cord compressions, and the need for radiation or surgery — in people with…
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