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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 therapyApproaches to treatmentCurrent treatment options and standard of care

KIT tyrosine kinase inhibitors

2 evidence topics · 5 sources

Existing FDA-approved targeted treatment: avapritinib

“Trade Name: Ayvakit” (opens the source at this quote in a new tab)

“Marketing Approval Date: 05/22/2023” (opens the source at this quote in a new tab)

“Approved Labeled Indication: treatment of adult patients with indolent systemic mastocytosis (ISM)” (opens the source at this quote in a new tab)

Avapritinib dose for ISM

“The recommended dosage of AYVAKIT is 25 mg orally once daily in patients with ISM.” (opens the source at this quote in a new tab)