Bezuclastinib/Sunitinib NDA Accepted for Priority Review in Advanced GIST

Summary: Good news for patients with a type of stomach and gut cancer called GIST! The FDA is speeding up its review of a new drug combination. The new medicine, bezuclastinib, is taken with another drug called sunitinib.

In a recent study, this pair cut the risk of the cancer growing or causing death by 50%! Patients taking the combo lived an average of 16.5 months without their cancer getting worse, compared to just 9.2 months for those taking only sunitinib. While there are some side effects like high blood pressure and changes in liver tests, the results are very promising. The FDA will make its final decision by November 2026.

For more details, see rssapp-empr-com at empr.com/news/bezuclastinib-sunitinib-priority-review-gastrointestinal-tumors/ (opens in new tab)

Tags

Gastrointestinal Stromal Tumors
Disease Progression
Death
Disease
Neoplasms
Hypertension
Anemia
Diarrhea
Tyrosine Kinase Inhibitors
Protein-Tyrosine Kinases
Alanine
Aspartic Acid
Alanine Transaminase
Transaminases
Aspartate Aminotransferases
Neutropenia
Imatinib Mesylate