AstraZeneca beats revenue, profit estimates on resilient demand
BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib
AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.
AstraZeneca’s tablet formulation of Calquence (acalabrutinib) has been approved in the European Union (EU) for adults with chronic lymphocytic leukaemia (CLL). Calquence is a selective inhibitor of Bruton’s tyrosine kinase (BTK). It binds covalently to BTK, inhibiting its activity. According to AstraZeneca, in B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
Alembic's Generic Acalabrutinib Receives Approval in the U.S.
Chugai Pharmaceutical Co., Ltd. and Nippon Shinyaku Co., Ltd. announced that Chugai obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of CD20-positive chronic lymphocytic leukaemia (including small lymphocytic lymphoma).
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s new tablet formulation of CALQUENCE® (acalabrutinib) has been approved in the US for all current indications, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL), which is approved under accelerated approval based on overall response rate.
WILMINGTON, Del.--(BUSINESS WIRE)--Updated results from the ELEVATE-TN Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) maintained a statistically significant progression-free survival (PFS) benefit versus chlorambucil plus obinutuzumab and a safety and tolerability profile consistent with the known profile for CALQUENCE at a median follow up of approximately five years in combination and as a monotherapy in chronic lymphocytic leukemia (CLL).1