TOKYO, Japan I May 27, 2014 I Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Limited has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the indication expansion of Halaven(R) (generic name: eribulin mesylate, “eribulin”) to contribute to earlier-line treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Eribulin is currently indicated in Europe for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. The positive opinion received from the CHMP is a recommendation for the 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 have had less prior treatment.
The CHMP’s positive opinion is based on evidence from two pivotal Phase III studies, including the 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 at least two to five prior chemotherapeutic regimens including treatment with an anthracycline and a taxane, and a Phase III clinical study (Study 301) of eribulin versus capecitabine in women with locally advanced or metastatic breast cancer who had received prior treatment with an anthracycline and a taxane. These studies involved more than 1,800 patients, making this one of the largest data sets in metastatic breast cancer.
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: 35
TOKYO, Japan I May 27, 2014 I Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Limited has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the indication expansion of Halaven(R) (generic name: eribulin mesylate, “eribulin”) to contribute to earlier-line treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Eribulin is currently indicated in Europe for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. The positive opinion received from the CHMP is a recommendation for the 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 have had less prior treatment.
The CHMP’s positive opinion is based on evidence from two pivotal Phase III studies, including the 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 at least two to five prior chemotherapeutic regimens including treatment with an anthracycline and a taxane, and a Phase III clinical study (Study 301) of eribulin versus capecitabine in women with locally advanced or metastatic breast cancer who had received prior treatment with an anthracycline and a taxane. These studies involved more than 1,800 patients, making this one of the largest data sets in metastatic breast cancer.
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: 35
