The US Food and Drug Administration (FDA) has granted approval for Eisai’s Halaven (eribulin mesylate) Injection (0.5mg/mL) to treat patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
The company noted that this is the second indication where Halaven has received FDA-approval.
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The approval was based on the results of the randomised, open-label, multi-centre, active-controlled Phase III trial (Study 309), which showed 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.
The trial’s secondary endpoint, median progression-free survival (PFS), was longer in patients with liposarcoma treated with Halaven than in those who received dacarbazine.
The company noted that adverse events observed in the trial were consistent with the known profile of Halaven.
The most common adverse reactions in study patients with liposarcoma and leiomyosarcoma treated with Halaven were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain and pyrexia.
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By GlobalDataSarcoma Alliance executive director Alison Olig said: "Although liposarcoma accounts for less than 1% of all malignant tumours, it is a challenging journey for patients, since diagnosis and treatment can be difficult.
"The approval of Halaven is important for these patients, as it represents a new treatment choice where limited options have existed."
Halaven was approved in the US in November 2010, for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens to treat metastatic disease.
The drug is claimed to be the first and only single agent to significantly extend overall survival in the third-line for patients with metastatic breast cancer.
Eisai product creation systems oncology product creation unit president Kenichi Nomoto said: "The initial approval of Halaven for metastatic breast cancer more than five years ago and today’s approval for advanced liposarcoma underscore the ability of this treatment to provide an overall survival benefit in two difficult-to-treat cancers.
"As a company focused on human health care (HHC), we are proud of our commitment to providing new treatment options to address the unmet medical needs of patients."
Image: Halaven (eribulin mesylate) Injection. Photo: courtesy of Eisai Inc.
