Keryx Biopharmaceuticals, Inc. (KERX) announced that the U.S. Food and Drug Administration has granted Fast Track designation for KRX-0401, the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Further, a Phase 3 trial investigating perifosine in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment with the FDA.
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