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 increasing vascular perfusion and permeability in tumor cores,*1 promotion of the epithelial state and decrease in the capacity of breast cancer cells to migrate.*2
In a Phase III clinical study (EMBRACE) of Halaven versus treatment of physician's choice (TPC) in 762 patients with advanced or recurrent breast cancer previously treated with an anthracycline and a taxane, Halaven showed an extended overall survival compared to TPC.*3 For use in the treatment of breast cancer, Halaven is currently approved in over 70 countries worldwide, including the United States, Japan and countries in Europe and Asia. The most common adverse events (incidence 25% and higher) in the Halaven arm of this study were asthenia (fatigue), neutropenia, alopecia, peripheral neuropathy, nausea and constipation.
In China, Halaven received New Drug Approval for the use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including and an anthracycline and a taxane in July 2019 based on the results of Study 304,*4 which was a Phase III clinical study 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 of progression-free survival over the comparator treatment vinorelbine. 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.
The number of women diagnosed with breast cancer in China has increased in recent years,*5 with an estimated 370,000 new cases of breast cancer and 100,000 related deaths in 2018.*6 Breast cancer is now the most frequently diagnosed cancer in Chinese women.*6
Eisai positions oncology as a key therapeutic area, and is aiming to create revolutionary new medicines with the potential to cure cancer. Lenvima(R) has been available in China as a treatment of patients with unresectable hepatocellular carcinoma who have not received prior systematic therapy 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.
*Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A’s Chinese subsidiary MSD China have been providing information about Lenvima in China.
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