FDA accepts NDA for acalabrutinib to treat relapsed/refractory mantle cell lymphoma .- AstraZeneca
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, announced that the FDA has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor.
The NDA is 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 have received at least one prior therapy. This follows the FDA�s recent Breakthrough Therapy Designation for acalabrutinib. Priority Review is granted to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The Prescription Drug User Fee Act (PDUFA) date is during the first quarter of 2018.
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