Bezuclastinib + sunitinib for Gastrointestinal stromal tumor (GIST), after imatinib
The FDA is expected to decide on Bezuclastinib + sunitinib for Gastrointestinal stromal tumor (GIST), after imatinib by November 30, 2026, under a NDA from Cogent Biosciences.
What is being decided
Cogent Biosciences has an NDA under FDA review for Bezuclastinib + sunitinib in Gastrointestinal stromal tumor (GIST), after imatinib. Priority review. In the Phase 3 PEAK trial, adding bezuclastinib to sunitinib extended median progression-free survival from 9.2 to 16.5 months in patients whose GIST had progressed on imatinib, which Cogent describes as the first treatment to beat an active comparator in a GIST trial. The FDA said it does not plan an advisory committee.
Who this decision matters to
Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract, arising from the interstitial cells of Cajal or their precursors. Most GISTs are driven by gain-of-function mutations in the KIT or PDGFRA genes. The development of targeted tyrosine kinase inhibitors like imatinib revolutionized GIST treatment and serves as a model for precision oncology.
Prevalence: About 4,000-6,000 new cases per year in the U.S.; true incidence may be higher as small GISTs are often incidentally discovered. See our full Gastrointestinal Stromal Tumor page for current treatments, recruiting trials, and community resources.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Where Gastrointestinal Stromal Tumor treatment stands today
Mutational testing of your GIST is essential, as specific KIT or PDGFRA mutations predict response to different targeted therapies. Clinical trials are evaluating next-generation TKIs, combination strategies, and novel targets for TKI-resistant disease. The Life Raft Group and GIST Support International provide excellent trial-finding resources. For KIT-mutant GIST resistant to multiple TKIs, trials of newer agents may offer benefit. PDGFRA D842V GISTs, previously resistant to imatinib, now respond to avapritinib. SDH-deficient GISTs (wild-type for KIT/PDGFRA) require specialized evaluation. Seek care at a sarcoma center with GIST expertise for optimal management.
Meanwhile, 66 Gastrointestinal Stromal Tumor trials are recruiting
Whatever the FDA decides here, research on Gastrointestinal Stromal Tumor does not stop. A few currently enrolling studies, US sites first:
Get notified when new gastrointestinal-stromal-tumor trials open or existing trials change status, add sites, or update eligibility.
Frequently asked questions
When will the FDA decide on Bezuclastinib + sunitinib?
The FDA's target decision date (PDUFA date) for Bezuclastinib + sunitinib in Gastrointestinal stromal tumor (GIST), after imatinib is November 30, 2026, disclosed by Cogent Biosciences. The agency can act before this date and occasionally runs past it.
What is Bezuclastinib + sunitinib being reviewed for?
Cogent Biosciences submitted a NDA for Bezuclastinib + sunitinib in Gastrointestinal stromal tumor (GIST), after imatinib. Priority review. In the Phase 3 PEAK trial, adding bezuclastinib to sunitinib extended median progression-free survival from 9.2 to 16.5 months in patients whose GIST had progressed on imatinib, which Cogent describes as the first treatment to beat an active comparator in a GIST trial. The FDA said it does not plan an advisory committee.
What happens after the Bezuclastinib + sunitinib decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Cogent press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.