FDA grants full approval to Blincyto as rare blood cancer therapy

12 July 2017

Californian biotech firm Amgen (Nasdaq: AMGN) now has full marketing approval in the USA for Blincyto (blinatumomab) in a particular kind of acute lymphoblastic leukemia.

Green-lighting the company’s supplemental Biologics License Application, the US Food and Drug Administration upgraded its accelerated approval status based on data from the Phase III TOWER and Phase II ALCANTARA studies, adding data on overall survival rates to the label.

After bullish overnight trading, shares in the company opened nearly 1% higher in New York today, and continued to rise through the morning.

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