The U.S. Food and Drug Administration granted fast-track designation to Cardiff Oncology Inc.'s colon cancer drug onvansertib.
The designation is meant to expedite the review of potential therapies for serious or life-threatening conditions. The status makes a therapy eligible for accelerated approval, priority review, or rolling review if certain criteria are met.
Onvansertib is intended as a second-line treatment for metastatic colorectal cancer in patients who have mutations in their KRAS gene. The drug is meant to be used with the existing standard of care for the disease: a combination of Roche Holding AG's Avastin, or bevacizumab, and chemotherapy drug Folfiri.
Cardiff Oncology is evaluating the drug in combination with Avastin and Folfiri to treat people with this condition under a phase 1b/2 trial.
Previously, the medicine, when combined with chemotherapy, showed an increase in response to treatment for certain patients with acute myeloid leukemia in an early-stage study. Onvansertib holds orphan-drug designation given by the U.S. regulator for the same indication.
San Diego-based Cardiff Oncology was formerly known as Trovagene Inc.