FDA approves new indication of AstraZeneca's Calquence

As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the Food and Drug Administration approved Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL.

This newly approved indication for Calquence provides a new treatment option for patients with CLL or SLL as initial or subsequent therapy.

Calquence is indicated to treat adults with mantle cell lymphoma who have received at least one prior treatment for their cancer.

“Today, as part of a U.S., Australian, and Canadian collaboration known as Project Orbis, the United States approved a new treatment option for those living with chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA's Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA's international partners," said Richard Pazdur,  director of the FDA's oncology center of excellence and acting director of the office of oncologic diseases in the FDA's center for drug evaluation and research. "We are pleased to continue working alongside our Australian and Canadian colleagues to facilitate new treatment options for patients and the FDA looks forward to working with other countries in future application reviews."

CLL and SLL are similar cancers, but they occur in different areas of the body. CLL occurs mainly in the blood and bone marrow, while SLL occurs mainly in the lymph nodes. Both are cancers of lymphocytes, which are a type of immune cell that helps the body fight infection. Symptoms of CLL or SLL include low red blood cell counts (anemia), low platelet counts, fatigue, enlarged lymph nodes, and a higher risk of infection.