CytRx wishes on STAR-1 in hopes FDA will accelerate tamibarotene
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
CytRx is "aggressively working to achieve our goal" of completing the pivotal Phase II STAR-1 trial of oral tamibarotene for third-line treatment of acute promyelocytic leukemia by year-end, the company says June 29. The effort "may include acceleration of the trial through a negotiation with the FDA regarding the total number of patients ultimately enrolled." CytRx has been taking advantage of FDA programs to speed development of drugs for high-need settings, like APL; according to the company, approximately 1,500 patients are diagnosed with the rare cancer annually in the U.S. Tamibarotene, which would be the first approval for APL, has orphan status and fast-track status for relapsed or refractory APL, and the open-label, non-randomized STAR-1 trial is being conducted under a Special Protocol Assessment. The pivotal trial has enrolled 11 patients to date, and five of the patients have achieved a morphologic leukemia-free state, when no leukemia cells can be found in bone marrow, the company reports. MLFS is one of several criteria comprising the primary endpoint of durable complete response