Supplemental BLA submitted for Herceptin for advanced, HER2-positive adenocarcinoma of the stomach
Genentech announced that it submitted a supplemental Biologics License Application (sBLA) to the FDA for Herceptin (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer. This sBLA is based on positive results from a Phase 3 study, known as ToGA, which showed that people who received Herceptin plus chemotherapy (Xeloda [capecitabine tablets] or intravenous 5-flourouracil and cisplatin) lived longer compared to people who received chemotherapy alone. Overall survival (OS), the primary endpoint, was significantly improved in people who received Herceptin plus chemotherapy compared to those who received chemotherapy alone (HR=0.74, p=0.0046, median OS 13.8 vs. 11.1 months).
Herceptin is already approved 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. Additionally Herceptin is indicated for the 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).For more information call (650) 225-1000 or visit www.herceptin.com.