25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients with chronic lymphocytic leukaemia and small lymphocytic leukaemia.

This approval provides a new treatment option for patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) either as initial therapy or subsequent therapy. This indication was approved based on two pivotal phase III studies that compared Calquence to other standard treatments. Patients in the Calquence arms of both studies had a significantly longer period during which their disease did not worsen, than those patients in the comparator arms.

This is the second evaluation facilitated through Project Orbis, an initiative of the United States FDA Oncology Center of Excellence. Under this project, the FDA, Health Canada and the TGA collaboratively reviewed the application. This innovative evaluation process provided a framework for process alignment and management of evaluation issues in real-time across jurisdictions.

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