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.
FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.
