CALQUENCE Granted US Breakthrough Therapy Designation

AstraZeneca announced the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for CALQUENCE® (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults.

"This is an important regulatory milestone for our work in hematology and for patients living with chronic lymphocytic leukemia, a life-threatening disease," José Baselga, Executive Vice President, Oncology R&D, said. "The 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 favorable 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 with obinutuzumab, significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.

This is 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.

CALQUENCE is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina and recently Singapore and is being developed for the treatment of CLL and other blood cancers. In the US, this indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.

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