Eisai's Halaven (Eribulin Mesylate) Approved by NMPA for Locally Advanced or Metastatic Breast Cancer in China

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Eisai Announces NMPA Approval of Halaven (eribulin mesylate) for Locally Advanced or Metastatic Breast CancerEisai announced today that the National Medical Products Administration (NMPA) of China has approved its internally developed novel anticancer drug, Halaven (eribulin mesylate), for patients with locally advanced or metastatic breast cancer who have previously received at least two chemotherapy regimens, including anthracyclines and taxanes.

This approval is based on the results of Study 304, a multicenter, open-label, randomized, parallel-group Phase III study conducted in China. The study enrolled 530 female patients with locally recurrent or metastatic breast cancer who had previously received at least two and up to five prior chemotherapy regimens (including one anthracycline and one taxane), to evaluate the efficacy and safety of Halaven versus vinorelbine. In the study, patients were randomly assigned to receive either Halaven (1.4 mg/m² administered by intravenous infusion on Days 1 and 8) or vinorelbine (25 mg/m² administered by intravenous infusion on Days 1, 8, and 15) in 21-day cycles until disease progression. The primary endpoint was progression-free survival (PFS).

The results showed that, based on independent radiological assessment, the Halaven treatment group demonstrated a statistically significant improvement in PFS compared to the vinorelbine treatment group (HR=0.80, 95% CI: 0.65-0.98, p=0.036), thereby meeting the primary endpoint of the study. In terms of safety, the most common adverse events in the Halaven treatment group included decreased white blood cell count, decreased neutrophil count, elevated aspartate aminotransferase, elevated alanine aminotransferase, and anemia, which were consistent with the known side effects of Halaven.

Halaven is a synthetic analog of halichondrin B, a microtubule dynamics inhibitor with a novel mechanism of action. Halichondrin B is a compound isolated from black sponges found along the coast of Japan and has demonstrated efficacy in tumor treatment. In addition to its mechanism of inhibiting microtubule dynamic growth, non-clinical studies have shown that Halaven exerts unique effects on the tumor microenvironment, such as increasing vascular perfusion and permeability in the core region of tumors, promoting an epithelial phenotype, and reducing the migratory capacity of breast cancer cells.

Halaven, discovered and developed by Eisai, has been approved in more than 65 countries worldwide for the treatment of breast cancer. Additionally, the drug has also received approval in over 40 countries globally for the treatment of soft tissue sarcoma (STS). Currently, Eisai is investigating the potential of Halaven in treating various types of tumors, including bladder cancer, triple-negative breast cancer, and HER2-negative breast cancer.

Reference Source: ANTICANCER AGENT HALAVEN^® APPROVED FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC BREAST CANCER IN CHINA