Cogent Biosciences, Inc.
CRL AI-extracted
bezuclastinib
GIST who have received prior treatment with imatinib
Date
TBD
FDA decision · Date TBD estimated
What's at stake An FDA complete response letter on bezuclastinib for GIST who have received prior treatment with imatinib is in focus around Date TBD.
“Bezuclastinib - Expanded Access Program Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclast”

Provenance

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