Evicenter
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Bezuclastinib

Gastrointestinal stromal tumor

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

Executive summary

Conclusions

1 evidence topic · 4 sources

Summary

The reported PEAK results support a progression-free-survival and response-rate benefit for bezuclastinib plus sunitinib compared with sunitinib alone after prior imatinib. Overall-survival data remained immature. The application received Priority Review, and the reported target action date was November 30, 2026. The company continued to describe GIST approval as potential rather than completed.