FDA approves Novartis Scemblix for chronic myeloid leukemia

 

• Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments1
  
  
• In the pivotal Phase III ASCEMBL trial, Scemblix demonstrated significant and clinically meaningful superiority in major molecular response (MMR) rate vs. Bosulif®* (bosutinib) (25% vs. 13%) at 24 weeks, and more -than -three times lower discontinuation rates due to side effects (7% vs. 25%)2,3
  
  
• Additional Phase I data in patients with CML with the T315I mutation supported the FDA approval for a second indication in this patient population4
  
  
• With a new mechanism of action known in scientific literature as a STAMP inhibitor and clinical trials across treatment lines – including in the first-line setting –, Scemblix reinforces Novartis’ two-decade commitment to bring transformative therapies to people living with CML2-18

https://www.globenewswire.com/news-release/2021/10/29/2323914/0/en/FDA-approves-Novartis-Scemblix-asciminib-with-novel-mechanism-of-action-for-the-treatment-of-chronic-myeloid-leukemia.html