Fruquintinib [FRU1]

Fruquintinib for patients with either metastatic or locally advanced and inoperable colorectal cancer who have received 2 or more prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies with or without anti-VEGF agents and/or anti- EGFR-based agents AND for whom the combination of trifluridine plus tipiracil and bevacizumab is unsuitable where the following criteria have been met:

1. This application is both being made by and the first cycle of systemic anti-cancer therapy with fruquintinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a histologically confirmed diagnosis of adenocarcinoma of the colon or rectum.
3. The patient has either metastatic disease or locally advanced and inoperable disease.
4. The patient has been previously treated for metastatic or locally advanced and inoperable disease with 2 or more prior anticancer regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies. Note: the regimens of either FOLFIRINOX or FOLFOXIRI can be counted as 2 chemotherapy regimens.
5. The patient has been previously treated with anti-EGFR-containing chemotherapy or not. Please tick which option applies to this patient:

• yes, the patient has been previously treated with anti-EGFR-containing chemotherapy or
• no, the patient has not been previously treated with anti-EGFR-containing chemotherapy

6. The patient has been previously treated with an anti-VEGF-containing chemotherapy or not. Please tick which option applies to this patient:

• yes, the patient has been previously treated with an anti-VEGF-containing chemotherapy or
• no, the patient has not been previously treated with an anti-VEGF-containing chemotherapy

7. The patient has been previously treated with regorafenib or not. Please tick which option applies to this patient:

• yes, the patient has been previously treated with regorafenib or
• no, the patient has not been previously treated with regorafenib

8. The patient is unsuitable for treatment with the combination of trifluridine plus tipiracil and bevacizumab for one of the reasons listed below – please tick the appropriate box:

• the patient has already been treated with the combination of trifluridine plus tipiracil and bevacizumab or
• the patient has already been treated with trifluridine plus tipiracil or
• the patient has a contraindication to treatment with trifluridine plus tipiracil or
• the patient has a contraindication to bevacizumab or
• the patient has previously had poor or no responses to cytotoxic therapy and hence further treatment with cytotoxic chemotherapy is considered inappropriate or
• the patient has previously tolerated cytotoxic chemotherapy poorly and hence further treatment with cytotoxic chemotherapy is inappropriate

9. The patient has not been previously treated with fruquintinib unless transferring from a company early access scheme and all other treatment criteria on this form are fulfilled.
10. The patient has an ECOG performance status of 0 or 1.
11. The prescribing clinician understands that concomitant use of fruquintinib with strong or moderate CYP3A inducers should be avoided (see section 4.5 of the fruquintinib SPC).
12. The prescribing clinician is aware of the SPC 4.4 recommendation that in the view of the risk of arterial thromboembolic events, starting treatment with fruquintinib is avoided in patients with a history of thromboembolic events (including a DVT or PE) within the past 6 months or if they have a history of stroke and/or TIA within the last 12 months.
13. Fruquintinib is to be used as monotherapy.
14. Fruquintinib is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
15. A formal medical review as to whether treatment with fruquintinib should continue or not will be scheduled to occur no later than by the end of the 2nd (28-day) cycle of therapy.
16. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
17. Fruquintinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 03 July 2025

Additional information

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

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Note

The data on this page was produced using version 1.368 of the CDF list, downloaded from NHS England’s website on 03 July 2025 at 18:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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