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Gritstone drug gets US FDA fast-track designation for bowel cancer


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Gritstone drug gets US FDA fast-track designation for bowel cancer

Gritstone Oncology Inc. said the U.S. Food and Drug Administration granted fast-track designation for its Granite-001 for treating bowel cancer.

Granite-001 — the company's lead product candidate — is a personalized treatment that enables the immune system to fight cancer and is developed using Gritstone's proprietary Edge artificial intelligence platform.

The Emeryville, Calif.-based biotechnology company is evaluating the drug in a phase 1/2 trial with patients having common solid tumors.

The fast-track designation will qualify Gritstone to meet and communicate more frequently with the FDA during the development of Granite-001. It will also allow for the accelerated approval and priority review of the drug's application.

Gritstone develops tumor-specific cancer treatments for multiple types of the disease by leveraging the immune system to recognize and destroy tumor cells.