EMA Advisory Committee OKs New Use for Eisai’s Cancer Drug
Eisai’s European regional headquarters, Eisai Europe Ltd., has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on it anticancer agent Halaven (eribulin mesylate) for treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. Following approval for use in the treatment of metastatic breast cancer in the EU, this marks the second indication for which Halaven has received a positive CHMP opinion based on a statistically significant extension of overall survival.
Halaven is a halichondrin class microtubule dynamics inhibitor. It is currently approved for use in the treatment of breast cancer in approximately 60 countries, including Japan and countries in Europe and the Americas. Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016 and was approved in Japan for the treatment of soft tissue sarcoma in February 2016. Halaven has been designated as an orphan drug for soft-tissue sarcoma in the United States and Japan.