VEGFR Inhibitor Fruquintinib Receives Fast Track Designation for Metastatic Colorectal Cancer
Posted: Monday, June 22, 2020
On June 18, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the VEGFR inhibitor fruquintinib for patients with metastatic colorectal cancer. Patient eligibility for treatment includes a history of fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, as well as VEGF biologic therapy. In addition, patients with the RAS wild-type gene are eligible for treatment with this agent if they were previously treated with EGFR therapy.
The Fast Track designation was based on the results from the FRESCO-2 clinical trial. Previous work included a phase III FRESCO study that led to fruquintinib’s approval for treatment of patients with metastatic colorectal cancer in China. In 2017, a multicenter, open-label phase IB study evaluated the safety, tolerability, and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The work evolved into proof-of-concept trials in 2019, which included patients with metastatic colorectal cancer and metastatic breast cancer. Currently, researchers are starting a phase III registration study of fruquintinib in refractory metastatic colorectal cancer in the United States, Europe, and Japan. Enrollment will be open to patients in 2020.
For more information regarding the phase III registry, visit ClinicalTrials.gov identifier NCT04322539.