Eisai says European Commission backs Halaven to treat of advanced Liposarcoma in Europe
pharmafile | May 5, 2016 | News story | Research and Development, Sales and Marketing | EC, Eisai, US FDA, oncology, regulation, soft tissue sarcoma
The European Commission has backed marketing for the Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) to treat advanced soft tissue sarcoma.
The decision is based on the results of a late-stage study published in the medical journal, The Lancet, the company said in a statement.
Patrick Schöffski, University Hospitals Leuven, Belgium, said: “This decision marks an important milestone for people in Europe with advanced liposarcomas. There are currently limited treatment options available, but now, we are a step closer to being able to offer them a treatment with a proven overall survival benefit. Eribulin was the first-ever single agent therapy to show such a survival benefit, which makes today’s news all the more important for patients and clinicians across Europe.”
Only 50% of people with soft tissue sarcomas are expected to live for five years. About 29,000 people are diagnosed with soft tissue sarcomas each year, about 1% of all cancers diagnosed in Europe. Liposarcomas (adipocytic sarcomas) originate in fat cells and can occur anywhere in the body.
Eribulin is also indicated as a treatment for breast cancer.
Gary Hendler, chief executive for Eisai EMEA, said: “This is the second form of cancer in which eribulin has demonstrated an overall survival benefit when compared to active therapy.”
In January the US Food and Drug Administration (FDA) approved eribulin for the treatment of people in the US with unresectable or metastatic liposarcoma. License was granted in Japan to extend the indication of eribulin to treat patients with soft tissue sarcomas in February.
Anjali Shukla
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