trastuzumab (Herceptin)

following a full submission

trastuzumab 600mg/5mL solution for injection (Herceptin®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adult patients with HER2 positive metastatic breast cancer (MBC) and early breast cancer (EBC) in a range of settings (full details of licensed indication presented later in advice document).

Trastuzumab should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

SMC restriction: Subcutaneous trastuzumab injection is accepted for use in line with previous SMC advice for intravenous trastuzumab (this excludes its use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab).

In a phase III randomised, open-label clinical study in patients with HER2-positive early breast cancer, subcutaneous trastuzumab was non-inferior to intravenous trastuzumab for the co-primary pharmacokinetic and efficacy endpoints of serum trough concentration (Ctrough) at pre-dose cycle 8 before surgery and pathological complete response.