AstraZeneca has announced that Calquence (acalabrutinib) has been granted US Breakthrough Therapy Designation (BTD) for chronic lymphocytic leukaemia.
The US Food and Drug Administration (FDA) granted the designation as a monotherapy treatment for adult patients with the disease, based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials, which will serve as the foundation for regulatory submissions later this year.
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.
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.
The drug 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.
The designation is an “important regulatory milestone” according to José Baselga, executive vice president, Oncology R&D.
He continued to say that the BTD “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 decision marks the 10th BTD that AstraZeneca has received from the FDA since 2014.