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

pharmafile | August 1, 2017 | News story | Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, acalabrutinib, biotech, drugs, life sciences, pharma, pharmaceutical 

It’s been a rollercoaster week for AstraZeneca. Following the failure of its crucial Mystic trial for its immunotherapy drug Imfinzi, the company has unloaded a string of positive announcements to neutralise potential damage; this includes a massive $8.5 billion deal with MSD to develop further immunotherapy combinations and monotherapies, and the news that the FDA awarded Imfinzi with breakthrough therapy designation for non-small cell lung cancer.  

Now, a day later, the company has revealed that its drug acalabrutinib has also been granted the same breakthrough 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 breakthrough designation 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.”

Matt Fellows

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