3 May 2016 - Amgen today announced that the US FDA has accepted for priority review the supplemental biologics license application for Blinctyo (blinatumomab) to include new data supporting the treatment of paediatric and adolescent patients with Philadelphia chromosome‑negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.

Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The Prescription Drug User Fee Act target action date is 1 September 2016.

For more details, go to: http://www.amgen.com/media/news-releases/2016/05/fda-grants-priority-review-for-amgens-supplemental-biologics-license-application-for-blincyto-blinatumomab/