Capecitabine Accord is indicated for the treatment of: -for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1). - metastatic colorectal cancer (see section 5.1). - first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1). in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zercepac (trastuzumab), from Accord Healthcare, intended for the treatment of breast and gastric cancer.
Odonate Therapeutics, Inc. announced positive top-line results from CONTESSA, a Phase III study of tesetaxel in patients with metastatic breast cancer (MBC).
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabazitaxel Accord (cabazitaxel), from Accord Healthcare, intended for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.