News

The U.S. Food and Drug Administration (FDA) has cleared the launch of a Phase 1b trial to test STAR-LLD, Starton Therapeutics’ experimental continuous delivery of low-dose lenalidomide into the blood, in people with multiple myeloma. The U.S.-based study, expected to start in the last months of the year,…

Janssen is asking the U.S. Food and Drug Administration (FDA) to expand approval its cell therapy Carvykti (ciltacabtagene autoleucel) to allow for earlier treatment of people with relapsed or refractory multiple myeloma (RRMM). Carvykti is approved in the U.S. for people with heavily treated myeloma, or…

Carvykti (ciltacabtagene autoleucel) significantly reduces the risk of disease progression or death in adults with multiple myeloma who received one to three prior lines of therapy and failed to respond to standard Revlimid (lenalidomide). That’s according to the first data analysis, at nearly 1.5 years of follow-up,…

A gene therapy designed by Kelonia Therapeutics to work as an off-the-shelf or readily available CAR T-cell therapy for multiple myeloma showed early signs of safety and efficacy in mouse models of the disease and in non-human primates. Specifically, in a mouse model, CAR T-cells generated in vivo,…

Sarclisa (isatuximab), given on top of standard treatment with Kyprolis (carfilzomib) and the steroid dexamethasone, was found to delay disease progression by almost three years, on average, in people with relapsed or refractory — hard-to-treat — multiple myeloma, according to updated data from a Phase 3 clinical trial.

Survival outcomes for people with multiple myeloma have improved substantially over the last two decades, likely due to the availability of new, more effective treatments, according to a population-based study from Germany. Myeloma itself was the most common cause of death. But the new data also showed that people…

Most patients with hard-to-treat multiple myeloma given NXC-201 — Nexcella’s experimental point-of-care CAR T-cell therapy — as part of a clinical trial in Israel have responded to treatment, with the response appearing to be long-lasting and the side effects manageable. That’s according to up to nearly 1.5 years…

The U.S. Food and Drug Administration (FDA) has agreed to review an application that, if approved, would allow the cell therapy Abecma (idecabtagene vicleucel) to be given earlier to people with hard-to-treat multiple myeloma. An FDA decision is expected by Dec. 16, according to Abecma’s developers…

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 given a fast track designation to CB-011, an experimental CAR T-cell therapy being developed by Caribou Biosciences for people with relapsed or refractory multiple myeloma. Fast track status is given to investigational treatments with the potential to fill an…