21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the U.S. Food and Drug Administration granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukaemia or small lymphocytic lymphoma. 

This new approved indication for Calquence provides a new treatment option for patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) as an initial or subsequent therapy.

The supplemental approval of Calquence for patients with CLL or SLL was based on two randomized clinical trials that compared Calquence to other standard treatments. The first clinical trial involved 535 patients with previously untreated CLL. Patients receiving Calquence had a longer progression-free survival (the amount of time a patient stays alive without the cancer growing) compared to patients receiving other standard treatments. The second clinical trial included 310 patients with previously treated CLL. Patients receiving Calquence also had a longer progression-free survival than patients receiving other standard treatments.

Read FDA press release