FDA grants fast track status to fruquintinib for metastatic colorectal cancer
The FDA granted fast track designation to fruquintinib for treatment of certain patients with metastatic colorectal cancer.
The designation applies to use of the agent for patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and — if RAS wild-type — an anti-EGFR therapy.
Fruquintinib (Elunate; Hutchison China MediTech Limited, Eli Lilly) is a selective oral inhibitor of VEGFR 1/2/3.
The phase 3 FRESCO study showed fruquintinib improved OS among patients in China with metastatic colorectal cancer, leading to the agent’s approval in that country in 2018.
Hutchison China MediTech Limited, known as Chi-Med, is launching the phase 3 FRESCO-2 study to evaluate fruquintinib for treatment of patients in the U.S., Europe and Japan with refractory metastatic colorectal cancer.
Another trial is underway to evaluate the agent in combination with paclitaxel for second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma. Chi-Med also has entered into three collaboration agreements to evaluate fruquintinib in combination with PD-1 monoclonal antibodies.