Cephalon received a green light from the FDA for Treanda as a treatment for chronic lymphocytic leukemia (CLL). The company expects to make this injection therapy available next month.
This marks Cephalon’s second cancer drug approval. Trisenox was sanctioned for the treatment of relapsed or refractory acute promyelocytic leukemia in 2000 and was acquired by the firm from Cell Therapeutics in July 2005.
The Treanda go-ahead thus represents a milestone for Cephalon’s internal oncology business. It has been granted orphan drug status, which will provide exclusivity in CLL until March 2015.
Cephalon holds exclusive marketing and development rights in the U.S. The compound was licensed from Astellas Pharma, and in Germany, Mundipharma markets the drug under the tradename Ribomustin in indolent non-Hodgkin’s lymphoma, multiple myeloma, and CLL. SymBio Pharmaceuticals holds exclusive rights to develop and market the API in Japan and selected Asia-Pacific Rim countries.