Fruquintinib Granted US FDA Fast Track Designation for Metastatic Colorectal Cancer Treatment
London: Thursday, June 18, 2020 – Hutchison China MediTech Limited (Chi-Med) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the development of fruquintinib, targeting patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.
Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe, and Japan (clinicaltrials.gov identifier: NCT04322539). The study is expected to start enrolling patients in mid-2020. The U.S. FDA acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study, if positive; the prior positive Phase III FRESCO study demonstrating improvement in overall survival that led to fruquintinib approval for mCRC in China in 2018; and additional completed and ongoing supporting studies in mCRC; could support a New Drug Application (NDA) for the treatment of patients with mCRC in the third-line setting.
About Fast Track Designation
The FDA Fast Track Designation is designed to expedite the development and review of potential medicines for serious conditions that fulfill unmet medical needs. This designation allows for more frequent interactions with the U.S. FDA on the drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.
About Colorectal Cancer (CRC) in the U.S.
CRC is the third most common cancer worldwide, causing more than 880,000 deaths in 2018. In the U.S., CRC is the fourth most common cause of new cancer cases, but the second leading cause of cancer deaths. It is estimated that in 2020, 147,950 people will be diagnosed with CRC and 53,200 people will die from CRC in the U.S.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability, and provide more consistent target coverage.
About Fruquintinib in mCRC
Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched by Eli Lilly and Company (Lilly) in late November 2018 under the brand name Elunate®. Elunate® is for the treatment of patients with mCRC that have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type).
In December 2017, Chi-Med initiated a multi-center, open-label, Phase Ib clinical study to evaluate the safety, tolerability, and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier: NCT03251378). The study progressed into proof-of-concept trials in 2019, including patients with mCRC and metastatic breast cancer. In February 2020, an End of Phase II (EOP2) meeting was held with the U.S. FDA, and regulatory interactions with the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are also underway.
Other Fruquintinib Development
- Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma.
- Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability, and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China.