AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Calquence (acalabrutinib) to treat adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
Calquence, which is a next-generation selective inhibitor of Bruton’s tyrosine kinase (BTK), binds covalently to BTK to inhibit its activity.
The FDA approval was based on data from the interim analyses of two phase III clinical trials, including Elevate-TN in patients with previously untreated CLL and Ascend in patients with relapsed or refractory CLL.
According to the company, both studies demonstrated that Calquence in combination with obinutuzumab or as monotherapy significantly minimised 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 assess the safety and efficacy of Calquence in combination with obinutuzumab or Calquence alone versus chlorambucil in combination with obinutuzumab in previously untreated patients with CLL.
Ascend is a global, randomised, multicentre and open-label phase III study designed to assess the efficacy of Calquence in previously treated patients with CLL.
Under the clinical development programme, AstraZeneca and Acerta Pharma are currently assessing Calquence in 23 company-sponsored clinical trials.
Calquence was already approved to treat adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in the US, Canada, Australia, Brazil, Qatar, UAE, Mexico, Argentina, Singapore, Chile and India.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “With over 20,000 new cases anticipated this year in the US alone, today’s approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile.
“The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.”
In October this year, AstraZeneca has secured FDA approval for its Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.