Regorafenib [REG3]

For patients with either metastatic or locally advanced and inoperable colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy and anti-EGFR-based treatment 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 regorafenib 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 metastatic or locally advanced and inoperable disease.
4. The patient has been previously treated for metastatic disease with, or is not considered a candidate for, fluoropyrimidine-containing chemotherapies which include 5-fluorouracil and/or capecitabine and/or tegafur but not necessarily trifluridine (plus tipiracil).
5. The patient has been previously treated with, or is not considered a candidate for, anti-EGFR-containing chemotherapy.
6. If the patient has previously been treated with trifluridine plus tipiracil (with or without bevacizumab) or not. Please tick which option applies to this patient:

• yes, the patient has been previously treated with trifluridine plus tipiracil or
• no, the patient has not been previously treated with trifluridine plus tipiracil

7. If the patient has been previously treated with fruquintinib or not. Please tick which option applies to this patient:

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

8. The patient has an ECOG performance status of 0 or 1.
9. The patient has not been previously treated with regorafenib.
10. Regorafenib is not to be used in combination with any other systemic anti-cancer therapy.
11. The prescribing clinician understands that concomitant use of regorafenib with strong CYP3A4 inhibitors and inducers should be avoided and that close monitoring of patients is required of patients on concomitant use of regorafenib and drugs which are BRCP substrates (see section 4.5 of the regorafenib SPC).
12. Regorafenib is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
13. A formal medical review as to whether treatment with regorafenib should continue or not will be scheduled to occur no later than by the end of the 2nd (28-day) cycle of therapy.
14. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break form to restart treatment.
15. Regorafenib will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 09 May 2023

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA866 (08 February 2023)

Current Form Version

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.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• REG3_prior_to_cdf_1.361
• REG3_prior_to_cdf_1.368