News

Janssen is seeking the approval of its investigational therapy teclistamab in the U.S. for people with relapsed or refractory multiple myeloma (RRMM). “Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high,” Peter Lebowitz, MD, PhD, global therapeutic area…

China’s National Medical Products Administration (NMPA) has conditionally approved a combination of Xpovio (selinexor) and the corticosteroid dexamethasone to treat adults with relapsed or refractory multiple myeloma (RRMM) who received at least three prior therapies. This includes patients whose disease failed to respond to at least one immunomodulatory…

Janssen has submitted an application to regulators in Japan seeking the approval of ciltacabtagene autoleucel, an investigational CAR T-cell therapy also known as cilta-cel, to treat relapsed or refractory multiple myeloma patients. The submission to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks that…

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…

Gracell Biotechnologies’ investigational new treatment for multiple myeloma, GC012F, has been named an orphan drug by the U.S. Food and Drug Administration (FDA). Orphan drug status is intended to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. It provides benefits…

Biohaven Pharmaceuticals has begun enrolling patients in its Phase 1a/1b trial testing the company’s antibody-recruiting molecule (ARM) called BHV-1100. The trial (NCT04634435) seeks to recruit 25 adults with newly diagnosed multiple myeloma who have minimal residual disease in first remission before a stem cell transplant. One patient…

The optimal dosing of tasquinimod, Active Biotech’s experimental oral therapy for adults with relapsed or refractory multiple myeloma, has been determined in a Phase 1b/2a clinical trial. Now, that dose and schedule will be tested, along with the standard oral combination treatment, in the trial’s second phase, the…

After promising early results, a sub-study of the DREAMM-5 platform trial is moving forward to its next phase to test a combination of Blenrep (belantamab mafodotin) with nirogacestat in adults with relapsed or refractory multiple myeloma. In addition, two sub-studies will be added to the trial (…

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…