With this approval, Herceptin is now available for patients with HER2-positive advanced or recurrent gastric cancer and HER2-positive breast cancer (advanced or recurrent / postoperative adjuvant chemotherapy) in Japan as well as US and Europe.
Chugai Pharma has submitted the application for the approval with the MHLW in March 2010.
The submission was supported by the results from a Phase III clinical study (ToGA) evaluated patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer.