Eisai’s anticancer agent treakisym for injection 100mg has received approval for an additional indication of chronic lymphocytic leukaemia (CLL) in Japan.
CLL is a blood cancer that is characterised by neoplastic transformation and excess propagation of a type of white blood cell called lymphocytes in the bone marrow.
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With the generic name bendamustine hydrochloride, treakisym was originally synthesised by German pharmaceutical company Jenapharm.
It is jointly developed and marketed in Japan by Eisai and SymBio Pharmaceuticals under an exclusive licensing agreement signed in August 2008.
The application for this additional indication was filed by Symbio in December 2015 following a development request from the Japanese Ministry of Health, Labour and Welfare's Study Group on Unapproved and Off Label Drugs with high unmet medical needs.
Nearly 2,000 patients are reported to suffer from CLL in Japan, which has recorded an incidence rate of new cases of approximately 0.3 in 100,000.
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By GlobalDataLaunched in December 2010 in Japan, treakisym received initial approval for relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma in October 2010. The drug is also designated as an orphan drug for CLL in Japan.
In Europe, it is currently marketed under the brand names Ribomustin and Levact as a treatment for non-Hodgkin's lymphoma, multiple myeloma and CLL.
The US Food and Drug Administration has also approved the drug, which is marketed under the brand name Treanda for the treatment of CLL and relapsed indolent B-cell non-Hodgkin's lymphoma.
Both companies have also signed an agreement in May 2009 for the development and marketing of treakisym in Singapore and South Korea.
