Postmarketing surveillance study of asciminib in patients with resistant/intolerant chronic myeloid leukemia in Japan - PubMed
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- #Postmarketing Surveillance
- #Asciminib
- #Chronic Myeloid Leukemia
- Postmarketing surveillance study of asciminib in resistant/intolerant chronic myeloid leukemia (CML) patients in Japan over 48 weeks.
- Safety analysis included 523 patients, with the approved dose of 80 mg daily most commonly used and not exceeded.
- Discontinuation rate was 28.5%, mainly due to adverse events (18.2%) including disease progression.
- Low incidences of safety specifications: myelosuppression (8.6%), pancreatitis (4.4%), QT interval prolongation (2.5%), infections (1.3%), vascular occlusive events (0.2%), and photosensitivity (0%).
- No notable trends in adverse drug reactions in patients aged ≥65 years or with renal, hepatic, or cardiac impairments.
- Cumulative major molecular response rate by week 48 was 61.2%, unaffected by age or comorbidities.
- Cumulative MR4.0 and MR4.5 rates by week 48 were 42.3% and 26.5%, respectively, with some patients having baseline BCR::ABL1 mutations achieving these responses.
- Real-world outcomes support asciminib's safety and effectiveness for resistant/intolerant CML patients.