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FDA grants breakthrough therapy designation to acalabrutinib for mantle cell lymphoma
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The FDA granted breakthrough therapy designation to acalabrutinib for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy, according to the drug’s manufacturer.
Acalabrutinib (ACP-196, AstraZeneca) is a highly-selective, potent Bruton tyrosine kinase inhibitor.
The FDA based its decision on clinical data from the acalabrutinib development program — which includes both monotherapy and combination therapies for a broad range of blood cancers and solid tumors. Specifically, the phase 2 ACE-LY-004 clinical trial evaluated acalabrutinib in patients with relapsed or refractory mantle cell lymphoma.
“New treatments are urgently needed for people with mantle cell lymphoma who relapse or do not respond to current therapy,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued release. “Breakthrough therapy designation for acalabrutinib will help us bring this potential new medicine to appropriate patients as quickly as possible.”