FDA Grants Breakthrough Therapy Designation to Acalabrutinib for CLL


If approved, acalabrutinib (Calquence, AstraZeneca) will offer a chemotherapy-free treatment option for adults with chronic lymphocytic leukemia.

Officials with the FDA have granted Breakthrough Therapy Designation for acalabrutinib (Calquence, AstraZeneca) as a monotherapy for adults with chronic lymphocytic leukemia (CLL), according to a press release.

CLL is one of the most common types of leukemia in adults. Annually, there are an estimated 105,000 new cases globally and 20,720 new cases in the United States, with prevalence expected to keep growing, according to AstraZeneca. Acalubrutinib, a Bruton tyrosine kinase inhibitor, has the potential to offer patients a chemotherapy-free treatment option.

The designation is based on data from the interim analyses of the ELEVATE-TN and ASCEND phase 3 clinical trials.

The ELEVATE-TN study is evaluating the safety and efficacy of acalabrutinib alone or in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in previously-untreated patients. The study includes 535 patients randomized into 3 treatment arms: chlorambucil in combination with obinutuzumab, acalabrutinib (100 mg twice daily) in combination with obinutuzumab, and acalabrutinib monotherapy (100 mg twice daily). The primary endpoint is progression-free survival (PFS).

In the ASCEND trial, the efficacy of acalabrutinib is being tested in previously-treated patients with CLL. The study includes 310 patients randomized into 2 treatment arms: acalabrutinib monotherapy (100 mg twice daily) and either rituximab in combination with idelalisib or rituximab in combination with bendamustine.

Positive results from interim analyses of both trials showed that acalabrutinib monotherapy or in combination significantly increased PFS, with safety and tolerability that were consistent with its established profile.

“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 in a statement. “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.”

Acalabrutinib is currently approved in the United States for relapsed or refractory mantle cell lymphoma.


Calquence granted US Breakthrough Therapy Designation for chronic lymphocytic leukemia [news release]. AstraZeneca. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-granted-us-breakthrough-therapy-designation-for-chronic-lymphocytic-leukaemia-14082019.html. Accessed August 14, 2019.

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