Medicines Healthcare Products Regulatory Agency
CRC is an abnormal growth of cells that begins in a part of the large intestine called the colon. When the cancer is metastatic, this means that it has spread to other parts of the body.
In patients with metastatic CRC, fruquintinib stops tumours from making new blood vessels and therefore slows down the growth of cancer. Blood vessels would usually provide the tumour with nutrients and oxygen.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.??
Were 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 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.??
??ENDS??
Notes to editors?
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The new marketing authorisation was granted on 20/09/2024 to Takeda UK Limited
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This product was submitted and approved via a National procedure, as part of an Access Consortium New Active Substance Work-Sharing Initiative.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 02