AsianScientist (Sep. 12, 2018) – Hutchison China MediTech Limited (Chi-Med) has announced that its fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China (NMPA, formerly the China Food and Drug Administration). The drug is cleared for the treatment of metastatic colorectal cancer patients who have failed at least two prior systemic antineoplastic therapies.
Colorectal cancer is the second most common cancer type in China, with about 380,000 new cases diagnosed per year. There were approximately 1.5 million new colorectal cancer cases globally in 2015, and this number is expected to increase to approximately 1.7 million by 2020.
Existing treatments for colorectal cancer include fluoropyrimidine, oxaliplatin and irinotecan, anti-vascular endothelial growth factor or anti-epidermal growth factor receptor therapies. However, some colorectal cancer patients do not respond to these treatments.
A highly selective and potent small molecule oral inhibitor of vascular endothelial growth factor receptors 1, 2 and 3—known as fruquintinib—has shown promise in the treatment of chemotherapy and targeted therapy-resistant tumors.
In the FRESCO trial, a phase 3 trial evaluating fruquintinib efficacy and safety in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy, fruquintinib was shown to provide a statistically significant and clinically meaningful improvement in overall survival of patients versus placebo (9.3 months versus 6.6 months, respectively). The safety profile of fruquintinib was also deemed manageable.
Additionally, fruquintinib’s good kinase selectivity has been shown to limit off-target toxicity, raising its tolerability in patients. This allows fruquintinib to be evaluated in combination with other agents such as chemotherapies, targeted therapies and immunotherapies, thereby maximizing the number of potential patients who may benefit from this novel cancer treatment. Fruquintinib capsules will be marketed in China under the brand name Elunate®.
“[This] approval is a major achievement for Chi-Med,” said Mr. Simon To, chairman of Chi-Med. “Elunate® is the first home-grown, China-discovered and developed drug we are aware of to be unconditionally approved through a randomized clinical trial in China. This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China’s emerging biotech ecosystem.”
The article can be found at: Li et al. (2018) Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer.
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Source: Hutchison China MediTech Limited; Photo: Shutterstock.
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