Full European approval of Blincyto in rare leukemia

US biotech major Amgen (Nasdaq: AMGN) yesterday announced that the European Commission (EC) has granted a full marketing authorization for Blincyto (blinatumomab) based on the overall survival (OS) data from the Phase III TOWER study in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Conditional approval in this indication was granted by the Commission in November 2015. but that was contingent on data from a confirmatory trial before full approval could be approved.

“Blincyto is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care,” said David Reese, senior vice president of translational sciences and oncology at Amgen. “For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces Blincyto as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer,” Dr Reese noted.