Australian patients suffering from advanced liposarcoma, previously treated with chemotherapy, will now have access to Halaven (eribulin) on the Pharmaceutical Benefits Scheme (PBS) from 1 December 2017.(1)
Indicated for the treatment of patients with unresectable liposarcoma who have received prior chemotherapy for advanced or metastatic disease,(2) Halaven is the first systemic treatment with a proven overall survival benefit to be PBS-listed for previously treated, advanced or metastatic liposarcoma.(3)
Sarcomas are rare cancers, representing one percent of all adult malignancies.(3) Approximately 80 percent of sarcomas arise from soft tissue and the remaining 20 percent from bone.(3) Liposarcoma is a rare type of soft tissue sarcoma, which accounts for up to 18 percent of all soft tissue sarcomas.(4) It can occur in almost any part of the body, however more than half involve the thigh and up to a third involve the abdominal cavity.(4) Survival outcomes in patients with unresectable, locally advanced or metastatic disease, are generally poor and treatment options limited.(3)
“The PBS listing of Halaven for patients living with advanced liposarcoma, who have unfortunately failed on a prior chemotherapy regimen, is a welcome step forward for our patients,” Professor David Thomas
“The PBS listing of Halaven for patients living with advanced liposarcoma, who have unfortunately failed on a prior chemotherapy regimen, is a welcome step forward for our patients,” said Professor David Thomas, Director of The Kinghorn Cancer Centre and Head of the Cancer Division at the Garvan Institute of Medical Research.
“Halaven has demonstrated a significant overall survival benefit for this patient population, which has had a high level of unmet need,” Professor Thomas added.
The efficacy of Halaven is supported by the pivotal Phase 3 sarcoma study (Study 309).(2,3)
The study involved 452 patients who had locally recurrent, inoperable and/or metastatic soft tissue sarcoma of one or two subtypes – liposarcoma or leimyosarcoma and had received at least two prior chemotherapy regimens. In this study, a statistically significant improvement in overall survival (OS) of 7.2 months (P=0.006) was observed in patients with liposarcoma for the Halaven arm compared to the dacarbazine arm.(2,3)
The most common adverse events observed with Halaven greater than 10% of any grade were neutropenia, leukopenia, nausea, constipation vomiting, diarrhoea, fatigue, asthenia, pyrexia, alopecia, anaemia, decreased appetite, hypokalaemia, arthralgia/myalgia, back pain, headache, peripheral neuropathy, cough and dyspnoea, and urinary tract infections.(2,3)
Halaven is a first-in-class halichondrin B-based, microtubule-dynamics inhibitor, and is a structurally simplified synthetic version of halichondrin-B, a natural product isolated from the marine sponge – Halichondria okadai.(2)
“Eisai welcomes the availability of Halaven on the PBS from 1 December, which provides patients in Australia with a new PBS-listed treatment option for advanced liposarcoma. We continue to be committed to the discovery, development and access to treatments for rare cancers like advanced liposarcoma,” said Jaime McCoy, Director of Eisai Australia.
The PBS listing of Halaven for previously treated, advanced liposarcoma in Australia underscores Eisai’s human health care (hhc) mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of oncology and to addressing the unmet medical needs of patients and their families.
1). Australian Government Department of Health. Pharmaceutical Benefits Scheme. Available at www.pbs.gov.au
2). Halaven® Approved Product Information. November 2016
3). Schoffski. P, Chawla. S, Maki. R.G et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016; 387 (10028): 1629-37.
4). Rare Cancers Australia website. Accessed 26 September 2017. www.rarecancers.org.au/directory/240/liposarcoma
5). Australian Sarcoma Study Group website. Accessed 26 September 2017. http://www.australiansarcomagroup.org/about-sarcoma.html