The Medicines and Healthcare products Regulatory Agency (MHRA) approved the new medicine fruquintinib (Fruzaqla) to care for adult patients who have colorectal cancer that has spread (CRC). When all other therapies have failed, it is tried.

Metastatic cancer indicates that the disease has moved to other bodily regions. By preventing tumors from growing new blood vessels, fruquintinib reduces the progression of malignancy in patients with metastatic colorectal cancer. Normally, blood arteries would supply oxygen and nutrition to the tumor.

The application for approval was supported by evidence obtained via two main studies (FRESCO-2 and FRESCO). FRESCO-2 involved 691 adults with previously treated metastatic colorectal cancer. The study included patients who had disease progression on, or were intolerant to, chemotherapy, biologics, and trifluridine/tipiracil (TAS-102) and/or regorafenib.  

FRESCO was conducted only in China and involved 416 adults with previously treated metastatic colorectal cancer, who had disease progression during or after prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy. 

In FRESCO-2, people treated with Fruzaqla lived for an average of 7.4 months compared with 4.8 months for those who received placebo. The study also showed that people treated with Fruzaqla lived for an average of 3.7 months without their disease getting worse, compared with an average of 1.8 months for people who received placebo.

In FRESCO, people treated with Fruzaqla lived for an average of 9.3 months compared with 6.6 months for those who received placebo. The study also showed that people treated with Fruzaqla lived for an average of 3.7 months without their disease getting worse, compared with an average of 1.8 months for people who received placebo.

The approval of fruquintinib is for a recommended dose of 5 mg once daily for 3 weeks, followed by 7 days (1 week) of rest (no medicine). This is 1 cycle of treatment.  

One of the most common side effects of fruquintinib is a reduced number of blood platelets which can cause easy bruising or bleeding. Patients may also have some joint pain, and a decrease in their appetite.    

As with any medicine, the MHRA will keep the safety and effectiveness of fruquintinib under close review.  Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.   

Learn more: Fruquintinib approved to treat adult patients with metastatic colorectal cancer    - GOV.UK (www.gov.uk)