The U.S. Food and Drug Administration (FDA) has approved the CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) as a second line of treatment for adults with relapsed or refractory multiple myeloma (RRMM). The therapy was first approved by the FDA in 2022 for adults who received four or…
The Gabrail Cancer Center (GCC) in Canton, Ohio is the first site to open in a Phase 1b clinical trial that’s evaluating STAR-LLD, Starton Therapeutics’ investigational continuous delivery of low-dose lenalidomide, in people with multiple myeloma. “I’m thrilled to be the study’s lead investigator and excited about the…
Multiple myeloma patients undergoing a stem cell transplant in an outpatient setting spent about a week less in the hospital than those undergoing the procedure in an inpatient setting, a new study demonstrated. Data also showed that outpatient transplant — which does not require the patient to be hospitalized…
Aphexda (formerly motixafortide), BioLineRx’s experimental add-on therapy, greatly increased the number of blood stem cells collected for autologous stem cell transplants (ASCT), a life-extending treatment for multiple myeloma. While Aphexda generated more stem cells with fewer pre-treatments, it may also help patients who do not generate enough cells…
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…
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