The FDA recently approved acalabrutinib for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 

Both conditions are similar but occur in different parts of the body. While CLL is appears mainly in blood and bone marrow, SLL appears mainly in lymph nodes. Symptoms of CLL and SLL include low red blood cell counts, low platelet counts, fatigue, enlarged lymph nodes, and a higher risk of infection.

Approval of acalabrutinib was based on two clinical trials involving more than 800 patients. In both studies, patients receiving acalabrutinib had longer progression-free survival than currently available treatment options.

Rajat Bannerji, MD, PHD, Chief of Hematologic Malignancies at the Rutgers Cancer Institute of New Jersey explained how acalabrutinib works in a relatively quick period of time to potentially improve progression free survival, in an interview with MD /alert.

“These combinations, even with a limited period of treatment tend to have very high rates of patients becoming minimal residual disease negative, and the feeling is that the patients who become MRD- will have a longer period of progression free survival," he said.

This FDA approval was in collaboration with the Australian Therapeutic Goods Administration and Health Canada, known as Project Orbis. Under the project, pharmaceutical companies can submit oncology drug applications to the FDA and its international partners.