The European Commission has approved acalabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia, according to the agent’s manufacturer. 

The approval was based on results from two phase 3 clinical trials: ELEVATE-TN and ASCEND. The ELEVATE-TN trial assessed acalabrutinib plus obinutuzumab and acalabrutinib alone among 535 patients with CLL. Results showed reduction improved PFS and OS with the combination arm compared with chlorambucil plus obinutuzumab. 

The ASCEND trial included 310 patients who were randomized to receive acalabrutinib monotherapy or investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy. REsearchers reported 88% of patients treated with acalabrutinib had PFS at 12 months compared with 68% of patients on rituximab combined with idelalisib or bendamustine. 

“One of our biggest hurdles in treating chronic lymphocytic leukaemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities,”  Paolo Ghia, MD, Director, Strategic Research Program on CLL, Università Vita-Salute San Raffaele in Milan, and investigator of the ASCEND trial, said in a press release. “Today’s news marks great progress for patients in Europe, as the phase III clinical trials for [acalabrutinib] showed a significant improvement in comparison with current standard treatments.”

The Committee for Medicinal Products for Human Use of the European Medicines Agency offered a recommendation for approval in July 2020. 

“This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options,” Dave Fredrickson, Executive Vice President of the Oncology Business Unit at AstraZeneca,  said in the release. “As our first European approval in blood cancers, Calquence provides a new tolerable treatment option with uncompromised efficacy and the potential to positively impact the quality of life for thousands of patients living with chronic lymphocytic leukaemia.”

Acalabrutinib is approved for the treatment of CLL, small lymphocytic lymphoma and mantle cell lymphoma in the US.