FDA gives AstraZeneca 'priority review' for acalabrutinib

AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, announced on Wednesday that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib.

The FTSE 100 company described acalabrutinib as a “highly-selective, potent” Bruton tyrosine kinase (BTK) inhibitor.

“FDA's acceptance of the acalabrutinib application and Priority Review illustrates the impact it could have on patients with relapsed or refractory mantle cell lymphoma as we work to bring this potential medicine to those in need as quickly as possible,” said AstraZeneca’s chief medical officer and executive vice president of global medicines development, Sean Bohen.

AstraZeneca said the NDA was based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who had received at least one prior therapy.

It followed the FDA's recent ‘Breakthrough Therapy Designation’ for acalabrutinib.

The company said Priority Review was granted to applications for medicines that, if approved, would offer a “significant improvement” in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.

The Prescription Drug User Fee Act (PDUFA) date was during the first quarter of 2018.

“We believe acalabrutinib has the potential to be a very important treatment option for patients with this life-threatening blood cancer,” said Acerta Pharma chief executive Flavia Borellini.

“The FDA's NDA acceptance exemplifies our progress in the acalabrutinib development programme and continues our momentum as we seek to transform care for people with haematologic malignancies.”

AstraZeneca said results from the ACE-LY-004 clinical trial would be submitted for presentation at a forthcoming medical meeting.

The acalabrutinib development programme included both monotherapy and combination therapy strategies in a broad range of blood cancers and solid tumours.

It said the programme included the Phase III ACE-LY-308 clinical trial evaluating acalabrutinib as a first-line treatment for patients with MCL.