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Bezuclastinib

Gastrointestinal stromal tumor

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted April 2026
Last updated
76 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Place in treatment, anticipated use, and care setting

1 evidence topic · 4 sources

Summary

The submitted application concerns GIST after prior imatinib treatment. The pivotal comparison evaluates bezuclastinib in combination with sunitinib rather than as monotherapy. The sponsor’s expanded-access policy requires the patient to reside in the United States and requests to be submitted by the treating physician.