Eisai’s breast cancer drug Halaven could soon be available in Europe to treat liposarcoma, after regulatory advisors backed expanding its use.
Liposarcoma is a specific type of soft tissue sarcoma that occurs in fat cells. The disease is rare and has a poor prognosis - just 50 percent of patients are expected to live five years.
According to Eisai, Halaven (eribulin) is the first and only single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma.
The Committee for Medicinal Products for Human Use endorsed the new indication for the drug after Phase III data showed a median 7.2 month increase in overall survival compared to dacarbazine (15.6 months versus 8.4 months) for patients with unresectable advanced or metastatic liposarcomas.
The study also showed the most common side effects to be fatigue, nausea, hair loss, constipation, peripheral neuropathy, abdominal pain and fever, as well as low levels of infection-fighting white blood cells or decreased levels of potassium or calcium.
Those of a more serious nature include a decrease in white blood cell count, which can increase the risk of serious infections that could lead to death; neuropathy; harm to a developing foetus; as well as changes in heartbeat (QTc prolongation), that could lead to death.
Halaven, which belongs to a class of antineoplastic agents, the halichondrins, that are derived from the marine sponge Halichondria okadai, was first approved for breast cancer in the US in 2010 and in the EU in 2011, and also won FDA clearance for liposarcoma back in January.