AstraZeneca PLC - Cambridge, England-based pharmaceutical firm - Says new tablet formulation of Calquence, whose generic name is acalabrutinib, has been approved in the US for all current indications. These include adult patients with chronic lymphocytic leukaemia, the most prevalent type of leukaemia in adults, and with blood cancer small lymphocytic lymphoma; and for patients with relapsed or refractory mantle cell lymphoma, an uncommon subtype of B-cell non-Hodgkin lymphoma. AstraZeneca says the approval by the US Food & Drug Administration was based on the Elevate-Plus trials, conducted in 116 healthy subjects.
AstraZeneca Executive Vice President Dave Fredrickson says: ‘Today’s approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukaemia and mantle cell lymphoma. This new option is a result of our focus on understanding the wants and needs of this community and providing patient-focused solutions for their treatment.’
Calquence is a selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity. In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
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