Eisai, a Japanese pharmaceutical company, receives New Drug Approval for its in-house developed anticancer agent Halaven.
The China National Medical Products Administration (NMPA) has approved the use of anticancer agent Halaven (eribulin mesylate) 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 anthracycline and taxane.
This approval is based on the results of the clinical trial study, which was a multicentre, open-label, randomized, parallel group Phase III clinical study. The study evaluated the efficacy and safety of Halaven and vinorelbine in 530 women with locally recurrent or metastatic breast cancer.
Halaven demonstrated a statistically significant extension in the study鈥檚 primary endpoint of progression-free survival (PFS) over the comparator treatment, vinorelbine according to independent imaging review.
Some of the 5 most common adverse events observed in the Halaven arm of the study include decreased white blood cell count, decreased neutrophil count, increased asparate aminotransferase, increased alanine aminotransferase, and anaemia, which is consistent with the known side-effect profile of Halaven.
The number of women diagnosed with breast cancer in China has risen in recent years, with an estimated 368,000 new cases of breast cancer and approximately 98,000 related deaths in 2018. Breast cancer is now the most frequently diagnosed cancer in Chinese women.
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 tumour microenvironment such as an increase in vascular perfusion and permeability in tumour cores, promotion of the epithelial state, decrease in the capacity of breast cancer cells to migrate, 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.
Click here for the complete issue.