TOKYO, Japan I May 7, 2013 I Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary, Eisai Europe Ltd., has filed an application with the European Medicines Agency (EMA) for anticancer agent Halaven(R) (eribulin mesylate, “eribulin”), requesting an indication expansion of eribulin to contribute to earlier-line treatment of patients with metastatic breast cancer.
Among the clinical evidence submitted with the application were results of a multicenter, randomized, open-label, Phase III clinical study (Study 301) that compared eribulin versus capecitabine in 1,102 patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. The majority of the patients received zero or one previous chemotherapeutic regimens for metastatic disease.
Also provided as clinical evidence was the outcome of a Phase III clinical study (Study 305: EMBRACE) of eribulin versus treatment of physician’s choice (TPC) in patients with locally advanced or metastatic breast cancer who had previously received two to five chemotherapeutic regimens. The study results demonstrate eribulin to be the first and only single-agent chemotherapy in the world to statistically, significantly extend overall survival compared to TPCs. Eribulin is currently indicated in Europe for the treatment of patients with locally advanced and metastatic breast cancer who have progressed after at least two chemotherapeutic regimens that included an anthracycline and a taxane for advanced disease. This latest application aims for an expansion of the current indication, which is limited to patients who have previously received at least two chemotherapeutic regimens, to include patients with metastatic breast cancer with less prior treatment.
Although advances are being made in the treatment of breast cancer each year with the development of new diagnostic technologies and anticancer agents, the unmet medical needs of patients with metastatic breast cancer continue to remain high. Eisai remains committed to providing scientific evidence aimed at maximizing the value of Halaven as it seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients with cancer and their families as well as healthcare providers.
SOURCE: Eisai
Post Views: 106
TOKYO, Japan I May 7, 2013 I Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary, Eisai Europe Ltd., has filed an application with the European Medicines Agency (EMA) for anticancer agent Halaven(R) (eribulin mesylate, “eribulin”), requesting an indication expansion of eribulin to contribute to earlier-line treatment of patients with metastatic breast cancer.
Among the clinical evidence submitted with the application were results of a multicenter, randomized, open-label, Phase III clinical study (Study 301) that compared eribulin versus capecitabine in 1,102 patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. The majority of the patients received zero or one previous chemotherapeutic regimens for metastatic disease.
Also provided as clinical evidence was the outcome of a Phase III clinical study (Study 305: EMBRACE) of eribulin versus treatment of physician’s choice (TPC) in patients with locally advanced or metastatic breast cancer who had previously received two to five chemotherapeutic regimens. The study results demonstrate eribulin to be the first and only single-agent chemotherapy in the world to statistically, significantly extend overall survival compared to TPCs. Eribulin is currently indicated in Europe for the treatment of patients with locally advanced and metastatic breast cancer who have progressed after at least two chemotherapeutic regimens that included an anthracycline and a taxane for advanced disease. This latest application aims for an expansion of the current indication, which is limited to patients who have previously received at least two chemotherapeutic regimens, to include patients with metastatic breast cancer with less prior treatment.
Although advances are being made in the treatment of breast cancer each year with the development of new diagnostic technologies and anticancer agents, the unmet medical needs of patients with metastatic breast cancer continue to remain high. Eisai remains committed to providing scientific evidence aimed at maximizing the value of Halaven as it seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients with cancer and their families as well as healthcare providers.
SOURCE: Eisai
Post Views: 106
