Evicenter
P&T meetings

Bezuclastinib

Nonadvanced systemic mastocytosis

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted December 2025
Last updated
62 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

Limitations of current therapies

2 evidence topics · 5 sources

Summary

Current care includes trigger avoidance, symptom-directed medicines, anaphylaxis preparedness, and treatment of skeletal complications. Avapritinib is FDA approved for adults with ISM. SUMMIT nevertheless enrolled participants with inadequate symptom control despite at least two anti-mediator therapies. The available evidence therefore describes a population with persistent symptoms on existing care; it does not establish that all treated people with nonadvanced SM require a KIT inhibitor. The effect of KIT inhibition on disease progression is not established.