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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. ....

Dai Maruyama , Japan General , United States , United Kingdom , Dave Fredrickson , Acerta Pharma , Rituximab Id , Astrazeneca Calquence , Acalabrutinib Acala , Adrian Kemp , National Cancer Institute , American Society Of Clinical Oncology , National Cancer Institute Information Service , European Hematology Association , Virtual Edition Of The European Hematology Association , Company On Twitter Astrazeneca , Japanese Ministry Of Health , Investor Relations Team , National Cancer Incidence , Department Of Hematology , American Cancer Society , Japanese Ministry , Clinical Oncologyin , East Asia , Cancer Institute Hospital , Japanese Foundation ,