pharmafileOctober 17, 2017
Tag: AstraZeneca , data
AstraZeneca has revealed that early-stage data concerning the efficacy of its acquired drug acalabrutinib in the treatment of blood cancers and solid tumours was invented and falsified.
AZ acquired the drug when it bought a majority stake in its developer, Acerta Pharma, in 2015 for $4 billion. Currently, AZ is investigating the performance of the drug in more than 25 trials comprising over 2,000 participants.
Four months earlier in August 2015, Acerta released an abstract detailing acalabrutinib’s effectiveness in treating solid tumours in mice. The company last month retracted this abstract, with AstraZeneca now confirmed that this was because the evidence detailed within was falsified, though pharma giant was quick to point out that this pre-dated its involvement with the drug.
A "former Acerta employee who acted alone to falsify a pre-clinical data set provided through external collaborations", has been blamed for the scandal.
Because the trial in data in question was generated from one of dozens of trials, and because it occurred months prior to AZ’s involvement with the drug’s development, the company has been keen to make clear that this revelation does not compromise acalabrutinib’s effectiveness, commenting: "It’s important to note that this isolated issue had no impact on the integrity of acalabrutinib data in any clinical trials, and there was no risk to patient health."
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