FDA Grants Fast Track designation To Keryx For KRX-0401

Keryx Biopharmaceuticals (Keryx) has received FDA Fast Track designation for KRX-0401 (Perifosine), an oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma. KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris in the US, Canada and Mexico.

Reportedly, a Phase 3 trial investigating perifosine in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA.

Ron Bentsur, CEO of Keryx, said: “This Fast Track designation can reduce the FDA review time of a new drug application, and therefore can expedite the time to market for perifosine in multiple myeloma.

“We believe that the Fast Track designation, together with the SPA and Orphan Drug status previously granted to us by the FDA for perifosine in multiple myeloma, significantly enhances the value proposition of perifosine in this indication. We are eager to begin the Phase 3 trial later this month.”