Policy & Regulation
AstraZeneca gains FDA Breakthrough Therapy Designation for Calquence for chronic lymphocytic leukaemia
15 August 2019 -

Science-led biopharmaceutical company AstraZeneca Plc (LON:AZN) announced on Wednesday the grant by the US Food and Drug Administration (FDA) of Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults.

According to the company, this is an important regulatory milestone for its work in haematology and for patients living with CLL, a life-threatening disease. Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile.

The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND phase III clinical trials. Together, the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.

This the 10th BTD that AstraZeneca has received from the FDA since 2014. An FDA BTD is designed to accelerate 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 may demonstrate substantial improvement on a clinically-significant endpoint over currently available medicines.

Currently, Calquence is approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, Qatar, the UAE, Emirates, Mexico, Argentina and recently Singapore and is being developed for the treatment of CLL and other blood cancers.

The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year, the company added.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, CVRM and Respiratory.