Posted by Michael Wonder on 14 Aug 2019
Calquence granted US breakthrough therapy designation for chronic lymphocytic leukaemia
14 August 2019 - Designation based on positive results from two Phase III trials.
AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia, one of the most common types of leukaemia in adults.
The FDA granted breakthrough therapy designation based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.
