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BTD for AZ's acalabrutinib in mantle cell lymphoma

01 August 2017 07:37

The US Food and Drug Administration has granted AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, breakthrough therapy designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

BTD is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.

Executive vice-president, global medicines development and chief mdical officer at AstraZeneca, Sean Bohen, said: "New treatments are urgently needed for people with mantle cell lymphoma who relapse or do not respond to current therapy. Breakthrough Therapy Designation for acalabrutinib will help us bring this potential new medicine to appropriate patients as quickly as possible."

Story provided by StockMarketWire.com

Related Company: AZN

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