EiSai announced that China approved Halaven (eribulin mesylate) for the treatment of locally advanced or metastatic breast cancer, for patients who were treated with two treatment including an anthracycline and a taxane. The approval was received from by National Medical Products Administration (NMPA).
The approval was based on study 304, a Phase 3 open label, randomised clinical trial. In the trial the safety and efficacy of Halaven was compared with vinorelbine, in patients previously treated with chemotherapy regimens, including an anthracycline and a taxane. Halaven showed statistically significant improvement in the progression free survival compared to vinorelbine.
The most common adverse events include reduction in the number of white blood cells, neutrophils, increase in aspartate aminotransferase, increased alanine aminotransferase and anemia.
Breast cancer in China
Breast cancer is most common cancer in Chinese women. It is estimated that 368,000 cases of breast cancer patients were present in China, with 98,000 deaths in 2018.
Halaven acts by inhibiting microtubules thereby preventing the cell inhibition. The other mechanisms of action include increased vascular perfusion, decreasing the capability of cancer cell to migrate, and epithelial state promotion.