Chugai Pharmaceutical Co., Ltd. has filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW), for antibody-drug conjugate “trastuzumab emtansine (T-DM1)” for the treatment of “HER2-positive metastatic or recurrent breast cancer.”
Chugai filed the application with the MHLW based on the results from an overseas phase III clinical trial (the EMILIA trial) and a domestic phase II clinical trial.
The EMILIA trial is an international phase III study comparing T-DM1 alone to lapatinib in combination with capecitabine in people with HER2-positive metastatic or unresectable locally advanced breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy. Japanese patients were not included in the EMILIA trial.
Chugai filed the application with the MHLW based on the results from an overseas phase III clinical trial (the EMILIA trial) and a domestic phase II clinical trial.
The EMILIA trial is an international phase III study comparing T-DM1 alone to lapatinib in combination with capecitabine in people with HER2-positive metastatic or unresectable locally advanced breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy. Japanese patients were not included in the EMILIA trial.
