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The FDA is expected to decide on Bezuclastinib + sunitinib for Gastrointestinal stromal tumor (GIST), after imatinib by November 30, 2026, under an NDA from Cogent Biosciences.
What the FDA is deciding on Bezuclastinib + sunitinib for Gastrointestinal Stromal Tumor
The FDA is reviewing Cogent Biosciences' application to approve Bezuclastinib + sunitinib for 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 the Bezuclastinib + sunitinib 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 6,000 new cases per year in the U.S. (American Cancer Society); 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 an approval or a rejection of Bezuclastinib + sunitinib 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. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Gastrointestinal Stromal Tumor treatment stands today
Read our full Gastrointestinal Stromal Tumor treatment summary
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.
The Gastrointestinal Stromal Tumor page has every treatment and trial →Meanwhile, 54 Gastrointestinal Stromal Tumor studies are recruiting or not yet recruiting
Whatever the FDA decides here, research on Gastrointestinal Stromal Tumor does not stop. The most recently updated:
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Frequently asked questions
When will the FDA decide on Bezuclastinib + sunitinib?
The FDA's target date (PDUFA date) for Bezuclastinib + sunitinib in Gastrointestinal stromal tumor (GIST), after imatinib is November 30, 2026.
Who disclosed it: Cogent Biosciences. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Cogent press release
What is Bezuclastinib + sunitinib being reviewed for?
Cogent Biosciences submitted an NDA for Bezuclastinib + sunitinib in Gastrointestinal stromal tumor (GIST), after imatinib.
What to know: 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.
Is there already an FDA-approved treatment for Gastrointestinal Stromal Tumor?
Yes. Trial Friend's drug list includes 2 FDA-approved drugs for Gastrointestinal Stromal Tumor.
Approved: Qinlock (ripretinib), Ayvakit (avapritinib).
Also coming: Bezuclastinib.
Check: the Gastrointestinal Stromal Tumor page also searches FDA drug labels for approved treatments.
Can I get Bezuclastinib + sunitinib before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 54 Gastrointestinal Stromal Tumor studies are recruiting or not yet recruiting. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Cogent Biosciences directly. Registered programs are listed on ClinicalTrials.gov.
How much will Bezuclastinib + sunitinib cost?
Cogent Biosciences has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Bezuclastinib + sunitinib decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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.