The FDA granted supplemental approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, this new approved indication for acalabrutinib provides a new option for patients with CLL or SLL as an initial or subsequent therapy.
“The FDA’s Project Orbis provides a framework for