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FDA grants breakthrough therapy designation to Calquence for chronic lymphocytic leukemia
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The FDA granted breakthrough therapy designation to acalabrutinib as monotherapy for adults with chronic lymphocytic leukemia.
Acalabrutinib (Calquence, AstraZeneca) — a Bruton tyrosine kinase inhibitor — is approved in the United States for treatment of adults with relapsed or refractory mantle cell lymphoma.
The agent also is being evaluated for treatment of other blood cancers, including CLL, diffuse large B-cell lymphoma, follicular lymphoma, Waldenström macroglobulinemia and multiple myeloma.
The FDA based the breakthrough therapy designation for CLL on results of two randomized phase 3 trials.
The ELEVATE-TN trial evaluated acalabrutinib alone or in combination with obinutuzumab (Gazyva, Genentech) versus chlorambucil plus obinutuzumab for treatment-naive patients. The ASCEND trial compared acalabrutinib with physician’s choice of two other regimens — rituximab (Rituxan; Genentech, Biogen) plus idelalisib (Zydelig, Gilead), or rituximab plus bendamustine — for previously treated patients.
Results of both trials showed acalabrutinib alone or as part of combination treatment significantly extended PFS.
In both trials, acalabrutinib exhibited a safety profile consistent with that observed in prior trials.
“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, MD, PhD, executive vice president for oncology research and development at AstraZeneca, said in a company-issued press release. “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.”
AstraZeneca expects to make regulatory submissions for acalabrutinib in CLL later this year based on results from ELEVATE-TN and ASCEND.