The 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.

FDA Breakthrough Therapy Designation 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. Use of acalabrutinib in adult patients with CLL is not yet FDA-approved.

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Posted 8/15/2019