Patricia Inácio, PhD, science writer —

The U.S. Food and Drug Admnistration will give priority review to Darzalex (daratumumab) as an add-on to standard treatments for multiple myeloma patients who cannot have a stem cell transplant. Janssen Biotech filed the supplemental Biologics License Application for Darzalex to be used in combination with either Velcade (bortezomib), Alkeran (melphalan),…

Gamida Cell is enrolling participants in a Phase 1 clinical trial of an immunotherapy for myeloma and non-Hodgkin’s lymphoma that is based on expanding the number of the body’s natural killer cells to fight the cancers. The study (NCT03019666) will assess the safety and preliminary effectiveness of the treatment in…

The European Commission has granted orphan drug status to CellProtect as a treatment for multiple myeloma, according to the investigational therapy’s developer, CellProtect Nordic Pharmaceuticals. Using patients’ own blood cells, CellProtect is made of a group of immune cells called natural killer (NK) cells that are activated…

The U.S. Food and Drug Administration (FDA) has accepted Ascentage Pharma‘s Investigational New Drug (IND) application for APG-1387, allowing Ascentage to test the anti-cancer drug candidate in clinical trials. APG-1387 is an inhibitor of a class of proteins called inhibitors of apoptosis (IAP) – a type of programmed…

The California Institute for Regenerative Medicine (CIRM) awarded a $19.8 million grant to Poseida Therapeutics to support the clinical development of their P-BCMA-101 investigational immunotherapy for relapsed and refractory multiple myeloma. P-BCMA-101 is undergoing testing in a Phase 1 clinical trial (NCT03288493) for multiple myeloma that…

The Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by National Health Service (NHS) in Scotland, has amended its initial decision and now recommends Janssen’s Darzalex (daratumumab) for patients with relapsed or refractory multiple myeloma. The decision was made after the pharmaceutical company offered to…

Myeloma UK has launched a new clinical trial to identify the best treatment options for myeloma patients classified as high-risk. The study is the first of its kind in the U.K. and one of the few that focus on high-risk myeloma patients, who represent a sub-group with urgent, unmet…

The first patient with relapsed/refractory multiple myeloma has been treated with the investigational therapy bb21217, according to the clinical-stage company bluebird bio. The treatment candidate bb21217, developed under a joint collaboration of bluebird bio and Celgene, is being tested in the two-part open-label Phase 1 CRB-402 study (NCT03274219),…

Newly-diagnosed multiple myeloma patients who are not eligible for a stem cell transplant reduce the risk of disease progression or death by half when Darzalex (daratumumab) is added to the combination of Velcade (bortezomib), melphalan, and prednisone, an interim analysis of a Phase 3 trial has revealed. The study, called ALCYONE (…

Kite Pharma has submitted an investigational new drug application to the U.S. Food and Drug Administration that would pave the way toward clinical trials of its myeloma therapy KITE-585. The agency must approve the application before Kite can begin testing the therapy in people with relapsed or refractory multiple myeloma. KITE-585 is a…