FDA approves new treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma

FDA approves new treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma

Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the U.S. Food and Drug Administration granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

The most common side effects of Calquence were anemia, neutropenia (abnormally low levels of white blood cells), upper respiratory tract infection, thrombocytopenia (abnormally low levels of platelets), headache, diarrhea and musculoskeletal pain (pain that affects the muscles and bones). Patients may experience atrial fibrillation and flutter and should be monitored for symptoms of arrhythmias (irregular heart beat). Patients may experience serious infections and should be monitored and treated promptly. Patients should also be monitored for bleeding and managed appropriately. Patients may also experience low blood counts and should have blood work monitored regularly. Patients should be advised to use sun protection as other malignancies, such as skin cancers and other solid tumors, have occurred in patients taking Calquence.

The FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Calquence. Women who are pregnant or breastfeeding should not take Calquence because it may cause harm to a developing fetus or newborn baby, or cause delivery complications.

For more information, please visit: Calquence.