FDA Approves Scemblix for Chronic Myeloid Leukemia First-Line Treatment
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Scemblix (asciminib) as a first-line treatment for adults newly diagnosed with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP). This approval marks a significant expansion of Scemblix's use, potentially benefiting four times as many patients as before. Scemblix has shown superior efficacy compared to all standard of care therapies, along with a favorable safety profile. The FDA's decision was based on results from the ASC4FIRST Phase III trial, which compared Scemblix to other tyrosine kinase inhibitors (TKIs). Key findings include:
- Nearly 20% more patients on Scemblix achieved major molecular response (MMR) compared to standard TKIs
- Scemblix showed superior efficacy with fewer severe side effects and treatment discontinuations
About Scemblix
Scemblix is a precision cancer medicine targeting the ABL myristoyl pocket (STAMP) in patients with CML. Asciminib was designed to help overcome mutations on the ATP-binding site of BCR-ABL1, which may help address resistance that occurs in later treatment lines of CML and is being studied in several clinical trials in hopes of helping patients across multiple treatment lines of CML.
As research continues, including ongoing analysis of the ASC4FIRST trial, the future looks brighter for those facing a CML diagnosis. This approval represents another step forward in the ongoing fight against leukemia, offering patients and their doctors a powerful new tool in managing this chronic condition.
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- Join the Conversation: CML Discussion Group
References:
Scemblix (Asciminib) Package Insert. https://www.novartis.com/us-en/sites/novartis_us/files/scemblix.pdf. Revised October 2024.
Hochhaus A, Wang J, Dong-Wook K, et al. Asciminib in Newly Diagnosed Chronic Myeloid Leukemia. N Engl J Med. 2024.
