News

Model May Better Classify Multiple Myeloma and Relapse Risks

A model that may better classify multiple myeloma (MM) using genetic sequence data from hundreds of patients has been developed. The model can identify specific genes and genetic alterations responsible for disease subtypes related to a risk of relapse, and it may contribute to the identification of targeted therapies,…

Janssen Seeks FDA Approval of Teclistamab for RRMM

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…

Xpovio Conditionally Approved in China for Heavily Treated Patients

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…

Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma

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…

FDA Approves 8th Darzalex Faspro Indication for Myeloma Patients

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…

1st Patient Enrolled in Phase 1 Trial of Antibody Therapy BHV-1100

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…

Optimal Dose of Tasquinimod Found in First Phase of RRMM Trial

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…

FDA Expects Decision on Cilta-cel Approval by February 2022

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…