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AZ acalabrutinib submission accepted by US FDA

02 August 2017 07:30

AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, have announced that the US Food and Drug Administration has accepted and granted priority review for the new drug application for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor.

AstraZeneca said the NDA was based on results from the phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who had received at least one prior therapy.

It said this followed the FDA's recent breakthrough therapy designation for acalabrutinib.

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