> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Breakthrough for Novartis’ Scemblix in Leukemia
- URL: https://www.fdaweb.com/breakthrough-for-novartis-scemblix-in-leukemia/
- Published: 2024-05-10T12:00:00.000Z
- Updated: 2026-09-14T14:30:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156962

FDA has granted Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Novartis says the designation was based on positive data from the Phase 3 ASC4FIRST study, in which Scemblix met both primary endpoints with superior major molecular response rates at week 48 compared to investigator-selected tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib and bosutinib) and compared to imatinib alone. Scemblix also showed a favorable safety and tolerability profile with fewer adverse events and treatment discontinuations vs. standard-of-care therapies, the company adds.