Innovive’s leukemia drug receives fast track status from FDA

The designation applies to the use of Tamibarotene in patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide. A pivotal phase II study of Tamibarotene will be initiated this summer, the company said.

A fast track designation speeds up the approval process to around six months in cases where typically patients have limited treatment options. Currently, patients who fail ATRA-based therapy are treated with arsenic trioxide, a compound administered intravenously and associated with significant toxicity including irregular heartbeat. There is no standard of care for patients who do not respond to ATRA and arsenic trioxide.

Tamibarotene is currently approved in Japan for treatment of recurrent APL. In a pivotal study, the effectiveness of orally administered Tamibarotene was evaluated for eight weeks in 39 Japanese patients with APL, including treatment-naive patients and patients previously treated with ATRA. The overall response rate in these patients was 61.5%. In patients with recurrent disease the overall response rate was 81%.

In conjunction with data from the pivotal Japanese study, data from Innovive’s pivotal study of Tamibarotene are expected to form the basis of a NDA with the FDA. An additional phase III study is currently underway in Japan comparing ATRA to Tamibarotene for the maintenance treatment of APL.