FDA Approves Eribulin for Unresectable, Metastatic Liposarcoma
The FDA has approved eribulin mesylate (Halaven) for the treatment of patients with unresectable or metastatic liposarcoma.
The U.S. Food and Drug Administration has approved eribulin mesylate (Halaven), a microtubule inhibitor, for the treatment of patients with unresectable or metastatic liposarcoma who have received prior chemotherapy, including an anthracycline.1
The American Cancer Society estimated that about 11 930 new soft tissue sarcomas were diagnosed in the United States in 2015, and approximately 4870 Americans died of the disease. 2 The most common types of sarcoma in adults are undifferentiated pleomorphic sarcoma, leiomyosarcoma, and liposarcoma.
“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.1 “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
Approval is based on a phase 3 pivotal trial that evaluated eribulin in 143 patients with locally advanced or metastatic liposarcoma who had previously been treated with chemotherapy.
The study also included 309 patients with leiomyosarcoma. Participants received either eribulin mesylate or dacarbazine until disease progression or unacceptable toxicity.
Results showed that median overall survival was 15.6 months with eribulin compared with 8.4 months with dacarbazine.
The most common adverse events associated with eribulin treatment were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. Patients receiving eribulin also experienced neutropenia, hypokalemia, and hypocalcemia.
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Clinicians should be aware that eribulin may cause leukopenia, which can increase the risk for developing serious infections, neuropathy, embryo-fetal toxicity, and QTc prolongation that could ultimately lead to death.
The recommended dose and frequency of eribulin mesylate in patients with advanced liposarcoma is 1.4 mg/m2 intravenously on days 1 and 8 every 21 days until disease progression or unacceptable toxicity.
Eribulin was initially approved by the FDA in 2010 for the treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens, including an anthracycline and a taxane, in either the adjuvant or metastatic setting.
- FDA approves first drug to show survival benefit in liposarcoma [news release]. Silver Spring, MD: U.S. Food and Drug Administration; January 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483714.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed January 28, 2016.
- What are the key statistics about soft tissue sarcomas. American Cancer Society website. March 16, 2015. http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-key-statistics. Accessed January 28, 2016.