CytRx’s Tamibarotene Receives Positive Opinion From EMEA

CytRx’s drug candidate, tamibarotene has received official notification from the Committee for Orphan Medicinal Products (COMP) of the EMEA.

Reportedly, a positive opinion was made regarding the application for orphan medicinal product for the treatment of acute promyelocytic leukemia (APL).

The favorable 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 FDA in October, said the company.

Steven Kriegsman, president and CEO of CytRx, said: We believe that the positive opinion by the COMP reflects the potential therapeutic value of tamibarotene as a treatment for European patients suffering from APL, especially for those who currently lack an effective third-line therapy for their disease. We consider this positive opinion important as it supports our ability to pursue marketing approval for tamibarotene in the EU in addition to our ongoing US clinical program.