Novartis has received US Food and Drug Administration (FDA) accelerated approval for Scemblix (asciminib) to treat adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in its chronic phase (Ph+ CML-CP). Scemblix, a “specifically targeting the ABL myristoyl pocket” (STAMP) inhibitor, is the first CML therapy to demonstrate efficacy along with a favourable tolerability and safety profile in comparison with imatinib and second-generation tyrosine kinase inhibitors (TKIs). The gold standard of business intelligence.
The FDA’s accelerated approval is based on the major molecular response rate (MMR) at week 48 from the Phase III, head-to-head, multi-centre, open-label, randomised ASC4FIRST trial. The study compared once-daily 80mg Scemblix to all other investigator-selected standard-of-care TKIs in 405 adults with Ph+ CML-CP. Novartis US president Victor Bulto stated: “Despite many advances in the field, patients still need treatment options that are highly effective with a favourable tolerability profile to help enable them to achieve meaningful outcomes as they manage chronic conditions.
” The approval was also backed by preliminary data from the Phase II ASC2ESCALATE study, which includes patients previously treated with one prior TKI. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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