FDA Fast Tracks Bayer's Cancer Drug
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.
The US FDA has granted fast-track designation for Bayer Healthcare's regorafenib for the treatment of gastrointestinal stromal tumours. If approved, the drug will be used to help patients whose tumours have progressed despite taking other drugs to treat them.
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.
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."
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