Is there a new drug approved for adults with newly diagnosed chronic myeloid leukemia?

Yes, there are new drug approvals for adults with newly diagnosed chronic myeloid leukemia (CML). In 2024, the FDA approved asciminib (brand name Scemblix) as a first-line treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic-phase CML (Ph+ CML-CP). Additionally, a new formulation of nilotinib called Danziten was approved for the same indication. These options add to the existing tyrosine kinase inhibitors (TKIs) like imatinib, dasatinib, and bosutinib.

What the research says

The ASC4FIRST trial, a phase 3 study, compared asciminib with investigator-selected TKIs (including imatinib, nilotinib, dasatinib, and bosutinib) in newly diagnosed CML-CP. At 96 weeks, 74.1% of patients on asciminib achieved major molecular response (MMR) compared to 52.0% on other TKIs, and 76.2% versus 47.1% in the imatinib stratum ⁷. Another study, the ASCEND trial, showed that asciminib as a single agent led to early molecular response in 93% of patients and MMR by 12 months in 79% ⁹. The FDA also approved Danziten (nilotinib) for newly diagnosed Ph+ CML-CP, based on prior trials showing nilotinib's efficacy ⁴. Earlier, the BFORE trial demonstrated that bosutinib achieved higher MMR rates at 12 months (47.2%) compared to imatinib (36.9%) in newly diagnosed patients ⁸. These approvals provide more effective and tolerable options for initial treatment.

What to ask your doctor

• Is asciminib (Scemblix) a good option for my newly diagnosed CML? What are its benefits and side effects?
• How does Danziten (nilotinib) compare to other TKIs for first-line treatment?
• Should I consider a second-generation TKI like bosutinib or dasatinib instead of imatinib?
• What are the monitoring schedules for molecular response with these newer drugs?
• Are there any financial assistance programs available for these newer medications?