Jul, 17 2019 09:20 JST

Source: Eisai

Eisai's Anticancer Agent Halaven Approved for Treatment of Locally Advanced or Metastatic Breast Cancer in China

TOKYO, Jul, 17 2019 - (JCN Newswire) - Eisai has received a New Drug Approval for its in-house developed anticancer agent Halaven (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA).

This approval is based on the results of Study 304,(1) which was a multicenter, open-label, randomized, parallel group Phase III clinical study, to evaluate the efficacy and safety of Halaven and vinorelbine in 530 women with locally recurrent or metastatic breast cancer, previously treated with chemotherapy regimens, including an anthracycline and a taxane. Halaven demonstrated a statistically significant extension in the study's 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).

The five most common adverse events observed in the Halaven 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 Halaven.

The number of women diagnosed with breast cancer in China has increased in recent years,(2) with an estimated 368,000 new cases of breast cancer and approximately 98,000 related deaths in 2018.3 Breast cancer is now the most frequently diagnosed cancer in Chinese women.(3)

Halaven 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 Halaven's unique actions on the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores,(4) promotion of the epithelial state, decrease in the capacity of breast cancer cells to migrate,(5) etc. For use in the treatment of breast cancer, Halaven is currently approved in over 65 countries worldwide, including the United States, Japan and countries in Europe and Asia.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Lenvima 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 Halaven, 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.

(1) Yuan P et al., Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomized clinical trial Eur J Cancer, 2019; 112, 57-65
(2) Lei F et al., Breast cancer in China. The Lancet Oncology, 2014; 15(7), e279'e289
(3) Ferlay J, et al., (2018). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. https://gco.iarc.fr/today(New Window), As of July 17, 2019
(4) Funahashi Y et al., Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sci., 2014; 105, 1334-1342
(5) 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

About Eisai
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

In its medium-term business plan EWAY2025, Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions), and is working on establishment of ecosystem platform business utilizing various data such as a large amount of clinical data, experiences, and know-how.

For more information about Eisai Co., Ltd., please visit https://www.eisai.co.jp.

Public Relations Department,
Eisai Co., Ltd.
Source: Eisai
Sectors: BioTech

Copyright ©2019 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release

Commencement of Major Renovation of Tsukuba Research Laboratories as Eisai Global Drug Discovery Center Aiming for Connecting Human and Human, and Data, and the World
December 10 2019 08:02 JST
Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer's Disease Using Blood
December 09 2019 08:36 JST
Eisai Satisfies All-Case Surveillance Condition for Approval of Anti-Cancer Agent Lenvima in Treatment of Thyroid Cancer
December 09 2019 08:17 JST
Eisai to Present New Research on Eribulin (Halaven) at 42nd Annual San Antonio Breast Cancer Symposium
December 05 2019 08:11 JST
Eisai to Present Latest Data on Alzheimer's Disease / Dementia Pipeline at 12th Clinical Trials on Alzheimer's Disease Conference
December 02 2019 08:23 JST
Eisai: Additional Indication for Lenvima (Lenvatinib) for Differentiated Thyroid Cancer Accepted in China
December 02 2019 08:08 JST
Eisai to Present Latest Data on Perampanel at the 73rd American Epilepsy Society Annual Meeting
November 26 2019 08:37 JST
Eisai's Equfina 50mg Tablets (Safinamide Mesilate) Launched in Japan
November 20 2019 13:01 JST
Eisai Transfers Rights to Receive Royalties Outside of Japan for EZH2 Inhibitor Tazemetostat to Royalty Pharma
November 05 2019 09:02 JST
Biogen Plans Regulatory Filing for Aducanumab in Alzheimer's Disease Based on New Analysis of Larger Dataset from Phase 3 Studies
October 23 2019 10:13 JST
More Press release >>

Latest Press Release

More Latest Release >>