Eisai Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Halaven® (eribulin mesylate) Injection (0.5 mg per mL) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. This marks the second indication for which Halaven has been approved by the FDA based on a statistically significant extension of survival.
“There is an unmet medical need for patients with soft tissue sarcoma whose disease no longer responds to treatment,” said George Demetri, MD, Professor of Medicine at Harvard Medical School and Director of the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute. “Halaven has been shown to help patients with advanced liposarcoma live longer, a meaningful result for patients with this rare and hard-to-treat disease.”
This approval was based on the results of the pivotal Phase 3 trial, Study 309, which demonstrated that previously treated liposarcoma patients who received Halaven (n=71) experienced a median overall survival (OS) 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. 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; HR 0.52; 95% CI: 0.35-0.78).
“Although liposarcoma accounts for less than 1% of all malignant tumors, it is a challenging journey for patients, since diagnosis and treatment can be difficult,” said Alison Olig, Executive Director at Sarcoma Alliance. “The approval of Halaven is important for these patients, as it represents a new treatment choice where limited options have existed.”
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%) in study patients with liposarcoma and leiomyosarcoma treated with Halaven were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%) and pyrexia (28%). The most common (?5%) Grade 3-4 laboratory abnormalities reported in patients receiving Halaven were neutropenia (32% vs. 8.9% in the dacarbazine arm), hypokalemia (5.4% vs. 2.8%) and hypocalcemia (5% vs. 1.4%). The most common serious adverse reactions reported in patients receiving Halaven were neutropenia (4.9%) and pyrexia (4.5%). The most common adverse reactions resulting in discontinuation of Halaven were fatigue and thrombocytopenia (0.9% each). Additional Important Safety Information including use in specific populations is presented below.