The US Food and Drug Administration has granted fast-track designation for Bayer Healthcare’s regorafenib for the treatment of gastrointestinal stromal tumours.
The fast-track process is designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need.
If approved, the drug will be used to help patients whose tumours have progressed despite taking other drugs to treat them.
Kemal Malik, head of global development and a member of the Bayer Healthcare’s executive committee, said: “There is a serious unmet medical need for this specific patient population. This milestone is an important step in the overall development of regorafenib.”
Regorafenib is an inhibitor that quells cancer cell growth and prevents new blood vessels that could feed tumours.
Bayer began enrolling patients in the drug’s Phase III trial in January, with a primary endpoint of progression-free survival, and secondary endpoints of overall survival, time to progression, disease control rate, tumour response rate, duration of response and safety.