FDA grants priority review for Amgen leukaemia drug
pharmafile | May 4, 2016 | News story | Research and Development, Sales and Marketing | Amgen, FDA, blincyto, leukaemia, lymphoblastic leukaemia, paediatric
Amgen has announced that the US Food and Drug Administration (FDA) has granted priority review status for the supplemental Biologics License Application for rare leukaemia drug, Blincyto (blinatumomab).
Blincyto is aimed at treating paediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). ALL is a rapidly progressing cancer of the blood and bone marrow and has become the most common type of cancer in children. Among the 2,500 children in the US diagnosed with the disease, 15-20% of those will experience relapse or fail to reach remission.
Blincyto absorbs T-cells to terminate leukaemia cells for patients whose cancer has returned, or who have not responded to previous treatment.
The priority review status is granted based on Blincyto’s potential to meet a significant unmet need, as well as results showing its efficacy in early Phase I/II trials. The Phase II study met its primary endpoint of complete remission within the first two cycles of Blinctyo treatment.
Sean E. Harper, executive VP of research and development at Amgen, says: “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%. 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.”
Amgen acquired Blincyto as part of its $1.16 billion acquisition of German biotech firm Micromet in 2012. The FDA previously approved the drug for another indication five months ahead of schedule.
Sean Murray
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