FDA approved Halaven (eribulin mesylate) Injection for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen, following priority review.
The approval was based on the results of a phase III trial, Study 309, which demonstrated that previously treated liposarcoma patients who received Halaven (n=71) experienced a median overall survival of 15.6 months compared with 8.4 months for those who received dacarbazine (n=72) (HR 0.51; 95% CI: 0.35-0.75), making it the first single agent to demonstrate an OS benefit in this stage of the disease, according to the drug’s sponsor, Eisai.
Median progression-free survival, the trial’s secondary endpoint, was longer in patients with liposarcoma treated with Halaven than in those who received dacarbazine (2.9 vs. 1.7 months; HR 0.52; 95% CI: 0.35-0.78).
The adverse events seen in Study 309 were consistent with the known profile of Halaven. Serious side effects from treatment with Halaven may include neutropenia, peripheral neuropathy, embryo-fetal toxicity and QT prolongation.
First in the halichondrin class, Halaven is a microtubule dynamics inhibitor with a distinct binding profile.
Halaven is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. Based on in vitro studies, Halaven exerts its effect via a tubulin-based antimitotic mechanism, ultimately leading to apoptotic cell death after prolonged and irreversible mitotic blockage.
Halaven was first approved in the U.S. in November 2010 for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Halaven was granted an FDA Orphan Drug Designation for soft tissue sarcoma in May 2012.
