Posted by Michael Wonder on 27 Jul 2020
Calquence recommended for approval in the EU by CHMP for chronic lymphocytic leukaemia
27 July 2020 - Recommendation based on two Phase III trials demonstrating superior progression-free survival across multiple settings while maintaining favourable tolerability
AstraZeneca’s Calquence (acalabrutinib) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from two Phase III clinical trials, ELEVATE TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL.
