following a second re-submission considered under the ultra-orphan and end of life process:
trastuzumab (Herceptin®) is accepted for restricted use within NHS Scotland.
Indication under review: in combination with capecitabine or fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. It is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
SMC restriction: for use in patients whose tumours have HER2 overexpression defined by immunohistochemistry (IHC) 3+ (“HER2 high expresser”).
The addition of trastuzumab to doublet chemotherapy improved overall and progression-free survival and tumour response.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice201KB (PDF)
Medicine details
- Medicine name:
- trastuzumab (Herceptin)
- SMC ID:
- 623/10
- Indication:
- in combination with capecitabine or fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. It is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
- Pharmaceutical company
- Roche
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Resubmission
- Status
- Restricted
- Date advice published
- 12 October 2015