Nov 21,2019: AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
This approval is based on positive reports from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL.
Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease development or death versus the comparator arms in both 1st-line and relapsed or refractory CLL.
Results from both trials shows that safety and tolerability of Calquence were consistent with its established profile.
This approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering incomparable efficacy and a constructive tolerability profile.
In the Calquence combination arm, risk of disease progression or death was reduced by 90%and in the monotherapy arm it was reduced by 80%. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-approved-in-the-us-for-adult-patients-with-chronic-lymphocytic-leukaemia-21112019.html