{"id":3018,"date":"2019-07-17T14:18:01","date_gmt":"2019-07-17T06:18:01","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=3018"},"modified":"2021-04-12T14:44:26","modified_gmt":"2021-04-12T06:44:26","slug":"anticancer-agent-eribulin-mesylate-approved-for-treatment-of-locally-advanced-or-metastatic-breast-cancer-in-china","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/en\/2019\/07\/17\/anticancer-agent-eribulin-mesylate-approved-for-treatment-of-locally-advanced-or-metastatic-breast-cancer-in-china\/","title":{"rendered":"ANTICANCER AGENT ERIBULIN MESYLATE APPROVED FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC BREAST CANCER IN CHINA"},"content":{"rendered":"

<\/p>\n

This approval is based on the results of Study 304,^{1<\/sup>\u00a0which was a multicenter, open-label, randomized, parallel group Phase III clinical study, to evaluate the efficacy and safety of eribulin and vinorelbine in 530 women with locally recurrent or metastatic breast cancer, previously treated with chemotherapy regimens, including an anthracycline and a taxane. Eribulin demonstrated a statistically significant extension in the study\u2019s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).<\/span>
\nThe five most common adverse events observed in the eribulin arm of this study were white blood cell count decreased, neutrophil count decreased, increased aspartate aminotransferase, increased alanine aminotransferase, and anemia, which is consistent with the known side-effect profile of eribulin.<\/span>
\n<\/span><\/p>\n}

The number of women diagnosed with breast cancer in China has increased in recent years,^{2<\/sup>\u00a0and breast cancer is now the most frequently diagnosed cancer in Chinese women.<\/span>^{3<\/span><\/sup>
\n<\/span><\/p>\n}}

Eribulin is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. In addition to its mechanism of action of inhibiting the growth of microtubule dynamics, non-clinical studies showed eribulin\u2019s unique actions on the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores,^{4<\/sup>\u00a0promotion of the epithelial state, decrease in the capacity of breast cancer cells to migrate,^{5<\/sup>\u00a0etc. For use in the treatment of breast cancer, eribulin is currently approved in over 65 countries worldwide, including the United States, Japan and countries in Europe and Asia.<\/span>
\n<\/span><\/p>\n}}

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Lenvima\u00ae has been available as a treatment of patients with unresectable hepatocellular carcinoma who have not received prior systematic therapy in China since November 2018. With this approval of eribulin, Eisai seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers in China.<\/span>
\n<\/span><\/p>\n

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Media Inquiries:
\nPublic Relations Department,\u00a0<\/span>
\nEisai Co., Ltd.<\/span>
\n+81-(0)3-3817-5120<\/span><\/p>\n

\u00a0<\/span><\/p>\n

[Notes to editors]<\/span><\/strong>
\n1. About Eribulin Mesylate<\/span><\/strong>
\nEribulin is in the halicondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, non-clinical studies showed eribulin\u2019s unique actions in the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores,^{4<\/sup>\u00a0promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate,^{5<\/sup>\u00a0and etc.<\/span>
\nEribulin was first approved as a treatment in the United States in November 2010 for patients with metastatic breast cancer. Eribulin is currently approved for use in the treatment of breast cancer in over 65 countries worldwide, including Japan and countries in Europe, the Americas and Asia. Furthermore, eribulin was first approved as a treatment for soft tissue sarcoma in the United States in January 2016, and is approved in over 60 countries including Japan and in Europe and Asia. Furthermore, eribulin has been designated as an orphan drug for soft tissue sarcoma in the United States and Japan.<\/span><\/p>\n}}

\u00a0<\/span><\/p>\n

Specifically, eribulin is approved for the following indications.\u00a0<\/span>
\nIn the United States for the treatment of patients with:<\/span><\/p>\n

\u2022\u00a0Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.<\/span><\/p>\n

\u2022\u00a0Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.<\/span><\/p>\n

In Japan for the treatment of patients with:<\/span><\/p>\n

\u2022\u00a0Inoperable or recurrent breast cancer<\/span><\/p>\n

\u2022\u00a0Soft tissue sarcoma<\/span><\/p>\n

In Europe for the treatment of adult patients with:<\/span><\/p>\n

\u2022\u00a0Locally advanced or metastatic breast cancer who have received a prior anthracycline-containing 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.<\/span><\/p>\n

\u2022\u00a0Unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.<\/span><\/p>\n

\u00a0<\/span>
\n2. About Study 304<\/span>^{1<\/span><\/sup><\/strong>
\nConducted in China, Study 304 was a multicenter, open-label, randomized, parallel group Phase III clinical study to evaluate the efficacy and safety of eribulin and vinorelbine in 530 female patients with locally recurrent or metastatic breast cancer, previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane. Patients received either eribulin (1.4mg\/m^{2<\/sup>\u00a0administered intravenously on Day 1 and Day 8 to 264 patients) or vinorelbine (25 mg\/m^{2<\/sup>\u00a0administered intravenously on Day 1, Day 8 and Day15 to 266 patients) every 21 days. The study\u2019s primary endpoint was progression-free survival (PFS).<\/span><\/p>\n}}}

<\/p>\n

^{1\u00a0<\/sup>Yuan P et al., Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomized clinical trial\u00a0Eur J Cancer,<\/i>\u00a02019; 112, 57-65
\n^{2\u00a0<\/sup>Lei F et al., Breast cancer in China.\u00a0The Lancet Oncology,<\/i>\u00a02014; 15(7), e279\u2013e289
\n^{3<\/sup>\u00a0Ferlay J, et al., (2018). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer.\u00a0https:\/\/gco.iarc.fr\/today<\/a>, As of July 17, 2019\u00a0^{\u00a0<\/sup>
\n^{4\u00a0<\/sup>Funahashi Y et al., Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models.\u00a0Cancer Sci.,\u00a0<\/i>2014; 105, 1334-1342
\n^{5\u00a0<\/sup>Yoshida T et al., Eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (EMT) to mesenchymal-epithelial transition (MET) states. Br J Cancer, 2014; 110, 1497-1505<\/p>\n","protected":false},"excerpt":{"rendered":"}}}}}}