Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved pemigatinib for reimbursement as a monotherapy treatment option for the treatment of adult patients 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.
This is written in the approval document as:
As monotherapy 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.
Reimbursement
CDS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | FGFR2::v | Cholangiocarcinoma | Elacestrant | |
| HSE (1) | FGFR2 rearrangements | Cholangiocarcinoma | Elacestrant |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-08-01 | Health Service Executive | Indication approved for reimbursement. |
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |