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Amgen's Blincyto Doubles Survival In TOWER

 
• By Alexandra Shimmings

The full data that led to Amgen Inc.'s Phase III TOWER study of Blincyto in acute lymphoblastic leukemia being stopped early in February have now been presented and show that treatment with the product nearly doubled overall survival. However, expectations were already high for the product and the data are unlikely to impact sales.

Blood cells
• Source: Shutterstock

Amgen Inc. plans to file for full approval of Blincyto (blinatumomab) based on the results of TOWER, which was a confirmatory trial required by the US FDA as part of the drug's accelerated approval process. Blincyto became the first anti-CD19 product to reach the US when it won accelerated FDA approval in December 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), well ahead of its 19 May 2015 Prescription Drug User Fee Act action date, and it later gained EU approval in November 2015. (Also see "Amgen gains early US win for BiTE antibody Blincyto" - Scrip, 4 December, 2014.)

This form of ALL is a rapidly progressing cancer of the blood and bone marrow, and has a median overall survival of just three to five months

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