The revised SmPC contains the following new indication for Herceptin (trastuzumab):

• Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti cancer treatment for their metastatic disease.
• Herceptin should only be used 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.

Revision of section 4.2 Posology and method of administration for early breast cancer 3 weekly schedule:
The information concerning posology and administration in early breast cancer using a 3 weekly schedule has been updated and reads as follows:
• Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the initial loading dose was well tolerated, the the subsequent doses can be administered as a 30-minute infusion.

SPC not yet updated electronically on EMC