The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Takeda’s Fruzaqla (fruquintinib) to treat adult patients with metastatic colorectal cancer (mCRC).
Fruzaqla is a selective oral inhibitor of all three vascular endothelial growth factor (VEGF) receptors (-1, -2 and -3), which play a key role in blocking tumour angiogenesis.
The drug works by blocking the formation of new blood vessels that would provide nutrients and oxygen to cancerous tumours, to stop the tumour from growing.
Fruzaqla was originally developed by China-based biopharmaceutical company Hutchmed, in collaboration with US drugmaker Eli Lilly, and marketed in China under the brand name ELUNATE.
In January last year, Hutchmed granted Takeda exclusive rights to further develop, commercialise, and manufacture Fruzaqla outside of Mainland China, Hong Kong, and Macau.
The UK regulator approved Fruzaqla for a recommended dose of 5mg once daily for three weeks, followed by one week of rest, which is considered one cycle of treatment.
MHRA healthcare quality and access interim executive director Julian Beach said: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
“We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”
The MHRA approval was supported by evidence from FRESCO-2 and FRESCO studies.
The FRESCO study was conducted in 416 adults in China with previously treated metastatic colorectal cancer, who had disease progression during or after prior chemotherapy.
In the study, people treated with Fruzaqla lived for an average of 9.3 months, compared with 6.6 months for those who received a placebo.
It also showed that people treated with Fruzaqla lived for an average of 3.7 months without their disease worsening, compared to an average of 1.8 months with a placebo.
The FRESCO-2 study enrolled 691 adults with previously treated metastatic colorectal cancer, including those who were intolerant to chemotherapy, biologics, and trifluridine/tipiracil or regorafenib.
In the FRESCO-2 study, people treated with Fruzaqla lived for an average of 7.4 months compared with 4.8 months for those who received a placebo.
Also, people treated with Fruzaqla lived for an average of 3.7 months without their disease worsening, compared to an average of 1.8 months with a placebo.
The most common side effects of Fruzaqla include a reduced number of blood platelets, which can cause easy bruising or bleeding, along with joint pain, and a decrease in appetite.
