The Medicines and Healthcare products Regulatory Agency (MHRA) has approved fruquintinib, known as Fruzaqla, for treating adults with metastatic colorectal cancer (CRC) in the UK.
This decision marks a significant step forward for patients whose cancer has spread and who have not responded to other treatments.
Fruquintinib: A New Hope for Metastatic Colorectal Cancer Patients
As of 20 September 2024, fruquintinib is now available to adult patients suffering from metastatic colorectal cancer. This form of CRC is particularly aggressive as it spreads beyond the colon, often leaving patients with limited treatment options.
Fruquintinib has been developed to target this challenging stage of cancer, giving new hope to those who have exhausted other treatments.
Julian Beach, MHRA’s Interim Executive Director for Healthcare Quality and Access, commented on the approval:
“Keeping patients safe and enabling their access to high-quality, safe, and effective medical products are key priorities for us.”
The approval of this medication comes after a thorough review of two key studies: FRESCO and FRESCO-2, which provided compelling evidence of fruquintinib’s effectiveness in prolonging the lives of patients with advanced colorectal cancer.
What Makes Fruquintinib Different?
Fruquintinib works by inhibiting the growth of new blood vessels, which tumours need to survive. Consequently, by blocking this angiogenic process, the drug effectively cuts off the tumour’s supply of essential nutrients and oxygen.
Furthermore, this deprivation slows down tumour growth, thereby inhibiting cancer progression. Additionally, this anti-angiogenic mechanism underscores fruquintinib’s potential as a targeted therapy.
This mechanism of action is particularly important for metastatic CRC, where tumours often become resistant to other forms of chemotherapy and biologics.
Clinical Trial Results: How Fruquintinib Performed
The drug’s approval was based on the results of two major studies, FRESCO and FRESCO-2. These trials demonstrated significant improvements in both overall survival and the time patients lived without their cancer worsening:
- FRESCO-2 (global): Participants treated with Fruzaqla lived for an average of 7.4 months, compared to 4.8 months for those given a placebo.
- FRESCO (China-based): Patients treated with the drug lived for 9.3 months on average, compared to 6.6 months with placebo.
Additionally, patients experienced longer periods without their disease progressing, with Fruzaqla nearly doubling the time patients lived without worsening symptoms compared to those on a placebo.
Study |
Median Overall Survival (Fruquintinib) |
Median Overall Survival (Placebo) |
Progression-Free Survival (Fruquintinib) |
Progression-Free Survival (Placebo) |
|---|---|---|---|---|
| FRESCO-2 | 7.4 months | 4.8 months | 3.7 months | 1.8 months |
| FRESCO | 9.3 months | 6.6 months | 3.7 months | 1.8 months |
Treatment Regimen and Side Effects
Fruquintinib is taken orally with a recommended dose of 5 mg per day for three weeks, followed by a one-week break. This treatment cycle is designed to give patients the best possible outcome with minimal interruptions.
Like all cancer treatments, fruquintinib comes with side effects. Commonly reported side effects include a reduction in blood platelets, leading to easier bruising or bleeding. Some patients also reported joint pain and loss of appetite.
However, the MHRA has assured that it will closely monitor the drug’s safety, as stated by Beach:
“As with all products, we will keep its safety under close review.”
Patients are encouraged to report any side effects directly through the MHRA Yellow Card scheme, ensuring ongoing monitoring of the medication’s performance in real-world conditions.
Fruquintinib’s Impact on the UK Health Landscape
Fruquintinib’s approval by the MHRA is a testament to the agency’s commitment to bringing new, life-extending treatments to those who need them most. It is part of a broader strategy to ensure that patients in the UK have access to cutting-edge therapies as soon as they become available.
The drug was fast-tracked through the Access Consortium’s New Active Substance Work-Sharing Initiative, further highlighting the importance of this approval.
For patients with metastatic CRC, this development provides a much-needed option in the fight against a disease that previously had limited avenues for treatment. With fruquintinib now in the mix, oncologists across the UK have an additional tool to help patients live longer, better lives.
Next Steps for Patients and Healthcare Providers
The MHRA continues monitoring fruquintinib’s safety and effectiveness and advises healthcare providers to review its dosing and potential side effects.
Patients who qualify should consult their oncologists to determine if fruquintinib suits them. Furthermore, its innovative mechanism and proven efficacy make fruquintinib a major leap forward in colorectal cancer treatment.
While it may not be a cure, it offers a vital lifeline for patients in the UK facing the challenges of metastatic CRC.
Sources: THX News & Medicines and Healthcare products Regulatory Agency.
