AstraZeneca scores second accelerated FDA review in 2 days for blood cancer drug

Now, a day later, the company has revealed that its drug acalabrutinib has also been granted the same accelerated review designation for the treatment of mantle cell lymphoma (MCL) in those who have received at least one prior therapy.

Acalabrutinib is a highly-selective Bruton tyrosine kinase inhibitor designed to treat B-cell cancers. The decision to provide accelerated review for the drug was based on the robust data supporting the drug’s efficacy, including a Phase 2 trial examining its effects on patients with relapsed or refractory MCL, and marks the fifth breakthrough therapy designation secured by AstraZeneca from the FDA in oncology since 2014.

"New treatments are urgently needed for people with mantle cell lymphoma who relapse or do not respond to current therapy," commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. "Breakthrough Therapy Designation for acalabrutinib will help us bring this potential new medicine to appropriate patients as quickly as possible."

Meanwhile, Flavia Borellini, Chief Executive Officer at Acerta Pharma noted: "This is an exciting regulatory milestone for our work in haematology. Acalabrutinib is a potent, irreversible BTK inhibitor with a high degree of specificity for its target. If approved, it could be a clinically-meaningful treatment option for patients with this devastating disease."