Ivosidenib monotherapy [IVO1]

For the treatment of patients with locally advanced or metastatic cholangiocarcinoma which has an isocitrate dehydrogenase-1 (IDH1) R132 mutation in patients with disease progression during or after previous systemic therapy and where the following criteria have been met:

1. This application for ivosidenib is being made by and the first cycle of systemic anti-cancer therapy with ivosidenib 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 or cytologically confirmed diagnosis of cholangiocarcinoma. Please also indicate below whether the cholangiocarcinoma is of intrahepatic or extrahepatic origin:

• the cholangiocarcinoma is of intra-hepatic origin Or
• the cholangiocarcinoma is of extrahepatic origin

3. The cholangiocarcinoma has been tested for isocitrate dehydrogenase-1 (IDH1) R132 mutation with a validated test and the result is positive.
4. The patient has unresectable locally advanced or metastatic disease.
5. The patient has been previously treated with systemic therapy for cholangiocarcinoma and the disease has progressed during or after such therapy. Such systemic therapy could have been in the adjuvant or neoadjuvant or advanced disease settings. Please also indicate whether the patient has received 1 or ≥2 lines of systemic therapy:

• the patient has been previously treated with 1 line of systemic therapy for cholangiocarcinoma Or
• the patient has been previously treated with ≥2 lines of systemic therapy for cholangiocarcinoma

6. The patient has an ECOG performance status of 0 or 1.
7. The patient either has no known brain metastases or if the patient has brain metastases, the patient is symptomatically stable prior to starting treatment with ivosidenib.
8. Ivosidenib will be used as monotherapy.
9. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner.
10. The prescribing clinician understands the following as regards the effect of ivosidenib on causing elongation of the heart rate corrected QT interval (QTc):

• an ECG prior to treatment initiation is necessary to check that the QTc interval is less than 450 msec and if the QTc interval is above 450 msec, management will be as stated in ivosidenib’s Summary of Product Characteristics (SPC)
• an ECG must be done at least weekly during the first 3 weeks of treatment and then monthly thereafter if the QTc interval remains at or below 480 msec (see SPC)
• concomitant administration of medicinal products known to prolong the QTc interval, or moderate/strong CYP3A4 inhibitors should be avoided whenever possible (see SPC).

11. Ivosidenib has important interactions with CYP3A4 inhibitors and inducers and other drugs and the prescribing clinician has considered these when prescribing ivosidenib (see SPC) and will continue to do so during treatment with ivosidenib.
12. The prescribing clinician is aware that monitoring with full blood counts and blood chemistry will be performed as outlined in ivosidenib’s SPC.
13. A first formal medical review as to whether treatment with ivosidenib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment
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 approval form to restart treatment.
15. Ivosidenib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 30 April 2024

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA948 (31 January 2024)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.