Genentech announced that Herceptin (trastuzumab) has been approved in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction, in patients who have not received prior medicines for their metastatic disease. This approval was based on results from the Phase 3 ToGA study which enrolled 594 patients with locally advanced or metastatic, HER2-positive stomach cancer. Data from the final overall survival (OS) analysis demonstrated Herceptin plus chemotherapy improved OS by 37% compared to chemotherapy alone (p=0.0038; median OS 13.5 vs. 11 months). An updated OS analysis based on an additional year of follow-up showed a 25% improvement in OS (p=0.02; median OS 13.1 vs. 11.7 months).

Herceptin is already indicated for the treatment of HER2-expressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel in patients who have not received chemotherapy. Herceptin is also indicated as adjuvant treatment in HER2-expressing, node-positive or node-negative breast cancer (as a single agent following multi-modality anthracycline based therapy; in combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or in combination with docetaxel and carboplatin).

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