NICE announces the recommendation of Amgen’s blinatumomab for treating acute lymphoblastic leukaemia (ALL). The indication is for patients in first complete remission with minimal residual disease (MRD) activity of at least 0.1%. This decision to recommend the drug as a cost-effective use of NHS resources was made after the submission of new evidence from the
A combination of a standard drug and the novel agent venetoclax – has been granted accelerated approval by the FDA for patients after a large, multicenter phase 1 clinical trial showed the combination had “promising efficacy” and was well tolerated in older AML patients. “I think it’s likely to become a standard for patients in
Astellas Pharma has received fast-track designation in the US for its FLT3 inhibitor, Gilteritinib, a drug that could potentially rival Novartis’ budding $250m-plus product Rydapt (Midostaurin). The FDA gave the status to Gilteritinib as a treatment for adults with FLT3-mutation-positive relapsed or refractory acute myeloid leukaemia (AML), a cancer that impacts blood and bone marrow.