following a full submission assessed under the end of life and orphan process:
pemigatinib (Pemazyre®) is accepted for use within NHSScotland.
Indication under review: for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
In a phase II, single-arm study, pemigatinib demonstrated anti-tumour activity in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with a FGFR2 fusion or rearrangement who have progressed on at least one line of prior systemic therapy.
This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- pemigatinib (Pemazyre)
- SMC ID:
- SMC2399
- Indication:
As monotherapy for the treatment of adults with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
- Pharmaceutical company
- Incyte Biosciences UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 07 February 2022