Cogent Biosciences To Initiate New Drug Application Submission For Bezuclastinib Under Real-Time Oncology Review
Benzinga Newsdesk 9 months ago
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- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in
- PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR of 46% in patients who had received prior treatment with imatinib
- Cogent is expected to initiate the RTOR process immediately; completion of the PEAK NDA submission expected in April 2026