Marta Figueiredo, PhD, science writer —

Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. According to a press release, the BLA now includes further details on the…

A Phase 1b clinical trial evaluating GlaxoSmithKline (GSK)’s belantamab mafodotin, in combination with SpringWorks Therapeutics’ nirogacestat, in people with relapsed or refractory multiple myeloma, has dosed its first patient, SpringWorks announced. The safety and preliminary effectiveness of this combination are being assessed as a sub-study in…

GlaxoSmithKline’s investigational therapy belantamab mafodotin has been recommended for approval in the European Union, by the Committee for Medicinal Products for Human Use (CHMP), for heavily treated multiple myeloma patients. The marketing authorization application, accepted for review in February, is specific for people with relapsed…

First-line maintenance therapy with Ninlaro (ixazomib) significantly delays disease progression or death in adults with multiple myeloma who had not been initially treated with an autologous stem cell transplant (ASCT), according to data from a Phase 3 trial. “There is a strong need for additional maintenance treatments for…

Despite some interruptions to melflufen‘s (melphalan flufenamide) clinical program due to the ongoing COVID-19 outbreak, Oncopeptides‘ application seeking its accelerated approval in the U.S. for the treatment of triple-refractory multiple myeloma will not be affected, and filing is expected mid-year, the company has announced. “Obviously the…

Cellectar Biosciences’ lead candidate CLR 131 safely and effectively prevents disease progression or reduces tumors in people with hard-to-treat multiple myeloma, according to data from a Phase 2 clinical trial. The results also showed notable response rates to CLR 131 in people with a range of…

Researchers are continuing to study how the combination of Oncolytics Biotech‘s virus-based anti-cancer therapy Reolysin (pelareorep) and Kyprolis (carfilzomib) provides benefits in multiple myeloma patients, according to a recent conference call. The two experts on the call focused on data from preclinical studies and…

Analysis Group is collaborating with China’s Institute of Hematology & Blood Diseases Hospital (IHBDH) to develop the country’s first blood disorders research platform to analyze real-world data in an effort to improve patient care. “Our goal is to set up a world-class hematological [blood disorders] research platform that…

Carmustine for Injection, a generic version of the chemotherapy BiCNU, has been launched in the U.S to treat people with multiple myeloma and other types of cancer. This follows the decision by the U.S. Food and Drug Administration (FDA) to approve STI Pharma‘s abbreviated new…

The European Commission has approved Darzalex (daratumumab), in combination with Revlimid (lenalidomide) and dexamethasone, as a first-line treatment for adults with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The decision was supported by the recent approval recommendation from the Committee for Medicinal Products for Human Use, an…