The U.S. Food and Drug Administration has approved Halaven (eribulin mesylate) Injection for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing chemotherapy regimen. Halaven is a microtubule dynamics inhibitor with a distinct binding profile that exerts its effect via a tubulin-based antimitotic mechanism, ultimately leading to apoptotic cell death after prolonged and irreversible mitotic blockage.
"Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time," Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug."
Halaven is also currently approved for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease (OT 12/10/10). And the drug had also received priority review designation for this indication last year (OT 10/25/15 issue); and was granted orphan drug designation for soft tissue sarcoma in 2012.
Safety and Efficacy
Efficacy and safety for Halaven were evaluated in a Phase III, clinical trial of 143 patients with advanced liposarcoma that was unresectable, locally advanced, or metastatic, all of whom had been treated with chemotherapy. Patients received either Halaven or dacarbazine until their disease had spread or until they were no longer able to tolerate the side effects of treatment. The median overall survival for patients with liposarcoma receiving Halaven was 15.6 months compared to 8.4 months for patients who received dacarbazine.
Side Effects
The most common side effects for the patients who received Halaven were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. Halaven may also cause neutropenia or decreased levels of potassium or calcium, according to a news release from the FDA. The most common serious adverse reactions for patients receiving Halaven were neutropenia and pyrexia.
Serious side effects from treatment with Halaven may also include a decrease in white blood cell count, which can increase the risk of serious infections that could lead to death; numbness or neuropathy; harm to a developing fetus; and changes in heartbeat that may also lead to death, according to the FDA.
Clinical Quick Facts
Drug: Halaven (eribulin mesylate) Injection
Approved Indication: Treatment of patients with unresectable or metastatic liposarcoma who have received prior anthracycline-containing chemotherapy regimen
Serious Side Effects: Neutropenia and pyrexia
Common Side Effects: Fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia