Research & Development
AstraZeneca gains US FDA approval for lymphocytic cancer drug Calquence
25 November 2019 -

The US Food and Drug Administration (FDA) has granted approval to United Kingdom-based AstraZeneca's Calquence (acalabrutinib) intended to treat adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), it was reported on Friday.

A next-generation selective inhibitor of Bruton's tyrosine kinase (BTK), Calquence binds covalently to Bruton's tyrosine kinase to inhibit its activity.

The approval was based on data from the interim analyses of two phase III clinical trials, including Elevate-TN in patients with earlier untreated CLL and Ascend in patients with relapsed or refractory CLL. According to the company, both studies showcased that Calquence in combination with obinutuzumab or as monotherapy significantly decreased the relative risk of disease progression or death against the comparator arms in both first-line and relapsed or refractory CLL. Elevate-TN is a randomised, multicentre and open-label Phase III study designed to evaluate the safety and efficacy of Calquence in combination with obinutuzumab or Calquence alone compared to chlorambucil in combination with obinutuzumab in earlier untreated patients with CLL.

AstraZeneca and Acerta Pharma are currently assessing Calquence in 23 company-sponsored clinical trials under the clinical development programme.