Evicenter
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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 therapyDisease description

Diagnosis

3 evidence topics · 5 sources

Diagnostic evaluation and screening

“Timely diagnosis of systemic mastocytosis (SM) remains challenging because of care heterogeneity.” (opens the source at this quote in a new tab)

Updated diagnostic criteria and classification of mast cell disorders

“CD30 expression in MC now qualifies as a minor SM criterion” (opens the source at this quote in a new tab)

Consensus diagnostic rule: major and minor criteria

“at least 1 major and 1 minor or 3 minor SM criteria are fulfilled” (opens the source at this quote in a new tab)