Japan approves anticancer agent for chronic lymphocytic leukemia
Treakisym is the result of a licensing agreement that involves Eisai and Symbio Pharmaceuticals Limited. It first gained approval in Japan six years ago, when it passed as a relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma treatment. Eisai has marketed Treakisym to Japan since December 2010.
Now, Treakisym has been approved as an orphan drug used to treat chronic lymphocytic leukemia in Japan. Symbio filed this latest application last December, after the Japanese Ministry of Health, Labor and Welfare’s Study Group on Unapproved and Off Label Drugs released a development request outlining high unmet medical needs.
Chronic lymphocytic leukemia, a blood cancer, is known for neoplastic transformation. It also causes large amounts of lymphocytes, a kind of white blood cell, to form within the patient’s bone marrow.
Approximately 2,000 patients living in Japan have chronic lymphocytic leukemia. The incidence rate of this disease’s new cases is 0.3 among 100,000, making it a disease that has high unmet medical need.
Eisai intends to develop revolutionary new medicines that may be able to cure cancer; the group sees this field of study as an important area that needs therapies immediately.
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