The U.S. Food and Drug Administration (FDA) is expected to decide by the end of February whether or not to approve ciltacabtagene autoleucel, known as cilta-cel, an investigational CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. The FDA extended its expected decision date to…
People with advanced multiple myeloma and diffuse large B-cell lymphoma (DLBCL) will soon be able to access Xpovio (selinexor) outside the U.S. through a managed access program. This program, also known as a named patient program, allows patients and doctors in countries where a medicine is not yet approved or…
C4 Therapeutics is preparing to launch a clinical trial testing its lead investigational therapy CFT7455 in multiple myeloma and other blood cancers. The U.S. Food and Drug Administration (FDA) approved the company’s application requesting a Phase 1/2a trial, which could open by mid-year. “With FDA clearance achieved, we…
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…
Adding Darzalex (daratumumab) to standard regimens for adults with relapsed or refractory multiple myeloma resulted in higher rates of deep and durable responses, according to exploratory analyses of two Phase 3 trials. These findings, from the ongoing POLLUX (NCT02076009) and CASTOR (NCT02136134) trials, were based on patients…
The Israeli Ministry of Health has approved Xpovio (selinexor), in combination with the corticosteroid dexamethasone, for the treatment of people with multiple myeloma who have received three or more prior therapies, and who failed to respond to at least one immunomodulatory agent, one proteasome inhibitor, and one CD38…
Heidelberg Pharma has been cleared in the U.S. to begin a clinical trial testing its investigational therapy HDP-101 for the treatment of multiple myeloma. The U.S. Food and Drug Administration (FDA) allowed the start of a Phase 1/2a trial following the submission of an investigational new drug…
Using an under-the-skin formulation of Velcade (bortezomib), in combination with Farydak (panobinostat) and oral dexamethasone, leads to a better safety profile in people with relapsed or refractory (resistant) multiple myeloma than does the therapy’s original into-the-vein version, data show. The triple combination treatment with under-the-skin Velcade also was…
China’s regulatory agency has approved the start of a Phase 3 clinical trial testing ATG-010 (selinexor), in combination with Velcade (bortezomib) and dexamethasone, in multiple myeloma patients after one to three prior lines of treatment. The trial will include about 150 patients in China with relapsed of refractory multiple…
An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients, its developer, Janssen, announced. An accelerated assessment, given to medications expected to have a major impact on public health, shortens the regulatory review process…
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