Real-Time FDA Review Of Bezuclastinib Combo In GIST Might Change The Case For Investing In Cogent Biosciences (COGT)
- Cogent Biosciences recently announced that the FDA agreed to review its New Drug Application for bezuclastinib plus sunitinib in previously imatinib-treated Gastrointestinal Stromal Tumor patients under the Real-Time Oncology Review program, supported by Phase 3 PEAK data showing longer progression-free survival and higher response rates versus sunitinib alone.
- An interesting aspect of this update is that the bezuclastinib combination could represent the first new treatment option in this GIST setting for more than two decades, potentially reshaping care pathways pending regulatory decisions.
- We will now examine how the Real-Time Oncology Review pathway for bezuclastinib in GIST may influence Cogent Biosciences’ investment narrative.
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