Posted by Michael Wonder on 29 Oct 2024
FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukaemia
29 October 2024 - Today, the FDA granted accelerated approval to asciminib (Scemblix, Novartis) for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase.
The efficacy of asciminib for newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase was evaluated in ASC4FIRST, a multi-centre, randomised, active-controlled, open-label trial.
