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AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).
As reported in a Nov. 9, 2020 press release, AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).
Approval of the therapy was granted by the European Commission and follows the positive opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The decision was based upon the positive results from two Phase III clinical trials, ELEVATE-TN and ASCEND.
“One of our biggest hurdles in treating chronic lymphocytic leukemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities,” said Paolo Ghia, director, Strategic Research Program on CLL, Università Vita-Salute San Raffaele in Milan, and investigator of the ASCEND Phase III trial, in the press release. “Today’s news marks great progress for patients in Europe, as the Phase III clinical trials for Calquence showed a significant improvement in comparison with current standard treatments.”
Dave Fredrickson, executive vice-president, Oncology Business Unit, added, in the press release, “This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options. 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 leukemia.”