Johnson & Johnson announced positive topline results from the investigational phase III MajesTEC-9 study of Tecvayli (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide.
FDA accepted a New Drug Application for iberdomide combined with standard treatment, daratumumab + dexamethasone, (also called IberDd )in patients with relapsed or refractory multiple myeloma. Iberdomide is part of an investigational, new class of medicines called cereblon E3 ligase modulator agents. FDA has granted a Prescription Drug User Fee Act date of Aug. 17 for this indication.
