EMEA committee recommends orphan drug status for CytRx's tamibarotene to treat APL

CytRx Corporation, a biopharma R&D company engaged in the development of high-value human therapeutics, has announced that its lead drug candidate tamibarotene has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of acute promyelocytic leukaemia (APL). 

The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. This favourable opinion for tamibarotene in the EU is in addition to the Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide granted by the US FDA in October 2007.