Acerta Pharma, the haematology R&D arm of AstraZeneca has had its New Drug Application for by the US Food and Drug Administration.
Acalabrutinib is a high-selective and potent Bruton tyrosine kinase (BTK) inhibitor.
The approval also saw the inhibitor being granted Priority Review by the FDA.
The NDA is 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 who have received at least one prior therapy.
This follows the FDA’s recent Breakthrough Therapy Designation for acalabrutinib.
Priority Review is 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.
Flavia Borellini, PhD, Acerta Pharma CEO, said: “We believe acalabrutinib has the potential to be a very important treatment option for patients with this life-threatening blood cancer.
“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.”