Havalen is a synthetic analogue of halichondrin B (http://www.chemdrug.com/article/8/), a microtubule kinetics inhibitor with novel mechanism of action.

 

 

 

Halichondrin B is a substance found on a black sponge growing along the coast of Japan, which can effectively treat tumors.

 

 

 

In addition to the mechanism of inhibiting microtubule dynamic growth, non-clinical studies have also shown that Halaven has unique effects on tumor microenvironment, such as increasing vascular perfusion and permeability in the core region of tumors, promoting epithelial status, and reducing the migration ability of breast cancer cells.

 

 

 

Havalen, discovered and developed by Sanitary Material, has been approved for breast cancer treatment in more than 65 countries worldwide.

 

 

 

Havalen has also been approved for the treatment of soft tissue sarcoma (STS) in more than 40 countries around the world. Currently, health materials are investigating Halaven's potential for treating various types of tumors, including bladder cancer, triple-negative breast cancer, HER2-negative breast cancer and so on.

 

 

 

The approval is based on the results of the study 304 study. This is a multi-center, open-label, randomized, parallel-group phase III study conducted in China. A total of 530 women with locally recurrent or metastatic breast cancer were enrolled. These women had received at least two or up to five chemotherapy regimens (including one anthracycline and one taxane) before, and Havalen and Vinorelbine were evaluated. The efficacy and safety of vinorelbine.

 

 

 

In the study, patients were randomly assigned to receive either Halaven (1.4 mg/m2, intravenous infusion on day 1 and 8) or vinorelbine (25 mg/m2, intravenous infusion on day 1, 8 and 15) for a 21-day cycle until the disease progressed. The primary endpoint was progression-free survival (PFS).

 

 

 

The results showed that, according to independent imaging examination, compared with vinorelbine treatment group, PFS in Havalen treatment group improved significantly (HR = 0.80, 95% CI: 0.65-0.98, P = 0.036) and reached the main end of the study.

 

 

 

Security aspects

 

 

 

The most common adverse events in the Halaven treatment group included decreased white blood cell count, decreased central granulocyte count, elevated aspartate aminotransferase, elevated alanine aminotransferase and anemia, consistent with known side effects of Halaven.