talazoparib (Talzenna)

following a full submission assessed under the end of life medicine process:

talazoparib (Talzenna®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

In a phase III study in patients with germline BRCA1/2-mutations and HER2-negative locally advanced or metastatic breast cancer who had received previous treatment with an anthracycline and/or a taxane), talazoparib significantly improved radiographic progression-free survival compared with physician’s choice of chemotherapy.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.