The Therapeutic Goods Administration (TGA) has approved the use of acalabrutinib (Calquence®) for the treatment of patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL).
This approval provides a new treatment option for patients with CLL or 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 Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). Under this project, the FDA, Health Canada (HC) 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.
Each regulator agency maintained its regulatory process to make independent decisions about the approval (market authorisation).
- CLL and SLL are similar cancers, but they arise in different areas of the body, CLL mainly in the blood and bone marrow, and SLL in the lymph nodes.
- CLL and SLL are cancers of lymphocytes, which are immune cells that help the body fight infection.
- CLL and SLL mainly affect the elderly population and are the most prevalent form of adult leukaemia.
- Common signs of CLL and SLL include enlargement of liver, spleen or lymph nodes, fatigue, anaemia, bruising, weight loss and frequent infections.