Posted by Michael Wonder on 01 Aug 2017
Acalabrutinib granted breakthrough therapy designation by US FDA for the treatment of patients with mantle cell lymphoma
1 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US FDA has granted breakthrough therapy designation for acalabrutinib for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase inhibitor in development for the treatment of multiple B-cell cancers.
The FDA granted breakthrough therapy designation based on the totality of clinical data from the acalabrutinib development programme, including data from the Phase II ACE-LY-004 clinical trial in patients with relapsed or refractory Mantle cell lymphoma.
