Ivosidenib in combination with azacitidine [IVO2]

For newly diagnosed and untreated adult acute myeloid leukaemia with an isocitrate dehydrogenease-1 (IDH1) R132 mutation in patients who are not eligible for standard induction chemotherapy where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with ivosidenib plus azacitidine will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has newly diagnosed acute myeloid leukaemia (AML).
3. The patient has a known IDH1 R132 mutation.
4. The patient has previously untreated AML and state below whether the patient has de novo AML or secondary AML.

• de novo AML
• secondary AML

5. The patient has the most recent bone marrow blast count:

• 20% to <30% blasts
• 30% to <50% blasts
• 50% or more blasts

6. The standard induction chemotherapy is unsuitable for this patient. Please mark below the dominant reason as to why this patient is unsuitable for intensive chemotherapy:

• age
• fitness
• significant comorbidity or comorbidities

7. The patient is fit for treatment with ivosidenib plus azacitidine and has an ECOG performance status (PS) of 0-3. Please mark below the ECOG PS status:

• PS 0
• PS 1
• PS 2
• PS 3

8. 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).

9. The prescribing clinician is aware that ivosidenib has important interactions with CYP3A4 inhibitors and inducers and other drugs and I have considered these when prescribing ivosidenib (see sections 4.4 and 4.5 of the SPC) and will continue to do so during treatment with ivosidenib.
10. Antifungal prophylaxis with posaconazole or voriconazole is to be given to this patient (unless there is intolerance of such antifungal prophylaxis) and thus the dosing of ivosidenib has taken this drug interaction into account with the ivosidenib daily dose prescribed at a reduced dose of 250mg as set out in section 4.5 of the Summary of Product Characteristics for ivosidenib. Note: if the patient develops toxicities to posaconazole and voriconazole such that these anti-fungal agents are discontinued, ivosidenib dosing should be increased to a maximum daily dose of 500mg. Note: for patients in the BioDrive AFS trial (NIHR trial ID 132674) who are randomised to the intervention biomarker arm, the requirement for antifungal prophylaxis with posaconazole or voriconazole is waived and ivosidenib dosing at a maximum daily dose of 500mg is funded.
11. Ivosidenib will be given in combination with azacitidine.
12. Ivosidenib plus azacitidine will be continued until disease progression or unacceptable toxicity or withdrawal of patient consent or an elective decision to discontinue treatment consequent to a sustained complete remission to therapy. Note: if ivosidenib is stopped for any of the above reasons, no further ivosidenib can be prescribed.
13. A formal medical review as to whether treatment with ivosidenib should continue will occur at least by the end of the second cycle of treatment.
14. When a treatment break of more than 10 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
15. Ivosidenib and azacitidine will be otherwise used as set out in their respective Summaries of Product Characteristics (SPC).

NHS funded From: 06 September 2024

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA979 (05 June 2024)

Current Form Version

Note

The data on this page was produced using version 1.341 of the CDF list, downloaded from an archive of NHS England’s website on 11 January 2025 at 21:05.

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.