FDA Grants Priority Review for Supplemental Biologics License Application of Amgen for BLINCYTO® (Blinatumomab)

Amgen Igea Luca Dezzani


May 3, 2016 

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for including new data supporting the treatment of adolescent and pediatric patients with Philadelphia chromosome‑negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

“Children and adolescents with ALL who experience a second or greater relapse or are refractory often have a dismal prognosis with survival rates below 10 percent. The FDA’s acceptance of the sBLA submission for BLINCYTO reinforces immunotherapy as a potential option for children in need of new treatments to fight this complex disease and help prevent further relapse,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

Priority review is assigned to applications for drugs that treat serious conditions. Furthermore, if approved, it would provide substantial improvements in the effectiveness or safety of the treatment, diagnosis or prevention of severe conditions. The target action date of the Prescription Drug User Fee Act (PDUFA) is Sept. 1, 2016.

ALL is a rapidly progressing and rare type of cancer of the blood and bone marrow impacting both children and adults. In fact, it is the most common type of cancer in children. Of the approximately 2,500 U.S. children and adolescents diagnosed with B-cell precursor ALL each year, around 15-20 percent (375-500) will experience relapse or fail to achieve recovery.


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