Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg and 400mg) for reimbursement as a monotherapy treatment option for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 with a CPS >= 1. Pembrolizumab (200mg) monotherapy's regime notes that this indication is an unlicensed dosing posology of pembrolizumab in Ireland, and that patients should be informed of this and consented to treatment in line with the hospital's policy on the use of unlicensed medication and unlicensed or 'off-label' indications. Please refer to this therapy's regime by the HSE for more information.

This is written in the approval document as:

As monotherapy for the treatment of recurrent, or metastatic cervical cancer with disease progression on or after chemotherapy in adults whose tumours express PD-L1 with a CPS >= 1

Citation

Pembrolizumab 400mg Monotherapy, 2023, version number 10, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/pembrolizumab-400mg-monotherapy-558.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Pembrolizumab