The United States Food and Drug Administration (FDA) has granted Innovive Pharmaceuticals, Inc. orphan drug designation for their agent tamibarotene for the treatment of acute promyelocytic leukemia (APL). The indication of the designation is for the treatment of APL that has relapsed or is refractory to all-trans-retinoic acid (ATRA) and arsenic trioxide.
Tamibarotene is a synthetic retinoid that has been designed to have approximately 10 times greater potency that ATRA. Tamibarotene remains at higher sustained plasma levels during administration than ATRA due to its lower affinity for cellular retinoic acid binding protein (CRABP).
Tamibarotene is already approved in Japan for APL, and has demonstrated significant activity as initial and subsequent therapy in APL.
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