FDA approves Halaven (eribulin mesylate) for liposarcoma- Eisai

The FDA has approved Halaven (eribulin mesylate) Injection (0.5 mg per mL), from Eisai, for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

This approval was based on the results of the pivotal Phase III trial, Study 309, which demonstrated that previously treated liposarcoma patients who received Halaven experienced a median overall survival (OS) of 15.6 months compared with 8.4 months for those who received dacarbazine, making it the first single agent to demonstrate an OS benefit in this stage of the disease. Median progression-free survival (PFS), a secondary endpoint, was longer in patients with liposarcoma treated with Halaven than in those who received dacarbazine (2.9 months vs. 1.7 months). 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. The most common adverse reactions (incidence greater than or equal to 25%) were fatigue (62%), nausea (41%) and alopecia (35%).

Comment: Halaven is currently filed in the EU and Japan for this indication. Liposarcoma (adipocytic soft tissue sarcoma) refers to tumors that arise from fat cells and can occur anywhere in the body. Liposarcomas make up approximately 17% of all cases of soft tissue sarcoma, accounting for about 2,000 new cases each year.