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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Calquence approved in Japan for CLL

  relapsed or refractory chronic lymphocytic leukaemia   progression after 12 months vs. 68% for comparators   AstraZeneca s Calquence (acalabrutinib), a next-generation, selective Bruton s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]).   The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ASCEND Phase III trial and a Phase I trial in Japanese patients, showing Calquence monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus a standard treatment of rituximab, a monoclonal antibody, combined with the physician s choice of idelalisib, a PI3-kinase inhibitor or bendamustine, a chemotherapy.

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