NMPA approves New Anti-Cancer Drug Halaven for Use in Patients With LocalIzed Advanced or Metastatic Breast Cancer

today, TheRegulatory Authority (NMPA) of China'sMedicines(http:// has approved its in-house development of the new anti-cancer drug Halaven (eribulin mesylin, ereblin), for localized or metastatic breast cancer patients who have previously received at least two chemotherapy regimens, including fentanyl and sequoiaabout Havalen
Havalen is aa halichondrin B) analogue of synthetic(http://, a microtubule dynamics inhibitor with novel mechanisms of actionHalichondrin B is a substance found on a black sponge grown off the coast of Japan that is effective in treating tumorsIn addition to the mechanism of action that inhibits microtubular kinetic growth, non-clinical studies have shown that Halaven has a unique role in tumor microenvironments, such as increasing vascular perfusion and permeability in the core areas of the tumor, promoting epithelial state, and reducing the ability of breast cancer cells to migrateHavalen has been approved in more than 65 countries worldwide for breast cancer treatment, discovered and developed by AishimaHavalen has also been approved for the treatment of soft tissue sarcoma (STS) in more than 40 countries around the worldCurrently, Wesfarmers is investigating the potential of Halaven to treat a variety of types of tumors, including bladder cancer, triple-negative breast cancer, HER2-negative breast cancer, and so onThis approval is based on the results of the Study 304 studyThis is a multi-center, open-label, randomized, parallel group III study conducted in China, and enrolled 530 women with localized relapse or metastatic breast cancer who had previously undergone at least 2 and up to 5 chemotherapy regimens (including a ring and one yew) to assess the efficacy and safety of Havlena and vinorelbineIn the study, patients were randomly assigned to Receive Halaven (1.4mg/m2, 1st and 8th Days of Intravenous Infusion) or Changchun Ruibin (25mg/m2, Day 1, 8th, 15th Day intravenous infusion) and 21 days for a cycle until the disease progressedThe main endpoint is Progresslifetime (PFS)The results showed that, according to the independent imaging examination, the HAValen treatment group had a statistically significant improvement in PFS compared to the Changchun Ruibin treatment group (HR:0.80, 95% CI: 0.65-0.98, p-0.036), which reached the main end point of the studysecurity
The most common adverse events in the Halaven treatment group included reduced white blood cell count, reduced central granulocytes count, elevated cytosine transaminase, elevated alanine transaminase, and anemia, consistent with halaven's known side effects