The U.S. FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval, part of Project Orbis, where the FDA sought to support oncology-based concurrent submissions with other authorities including the Australian Therapeutic Goods Administration (TGA) and Health Canada. The approval offers CLL and SLL patients additional therapy options.
Both CLL and SLL occur in different areas of the body although both are comparable. While CLL usually strikes in the blood and bone marrow, SLL attacks the lymph nodes. Both cancers are lymphocytes, representing a type of immune cell that helps the body fight infection. Both cancers lead to low red blood cell counts (anemia), low platelet counts, fatigue, enlarged lymph nodes and risk for infection.
What is Calquence?
The medication is used to treat a type of non-Hodgkin lymphoma known as mantle cell lymphoma. Specifically, it has been for patients previously treated with other therapies. By 2019, according to some reports it is unclear if the drug improves outcomes. It was approved for medical use in the United States in 2017. According to reports, whole sale costs by the end of 2018 was $14,064 USD per month.
The product was developed by Acerta and in 2016 announced that a majority stake acquired via AstraZeneca. It was disclosed some of the data associated with acalabrutinib was falsified. However, it was deemed to be an isolated incident.
FDA Oncology Center of Excellence Comments
Richard Pazdur, MD, 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 commented, “Today, as part of a U.S, Australian and Canadian collaboration known as Project Orbis, the U.S. approved a new treatment option for those living with CLL or SLL.”
Use of RTOR
The FDA utilized the Real-Time Oncology Review (RTOR) pilot program, designed to streamline the submission of data before the completion of the entire clinical application. Along with its Assessment Aid, which facilitated discussions among the regulatory agencies, the actual process was expedited as the FDA also granted the treatment Priority Review and Breakthrough Therapy designation to AstraZeneca.
The approval was based on a two randomized clinical trials comparing Calquence to other standard treatments including 1) 535 patient study with previously untreated CLL patients and 2)310 patient study with previously treated CLL. In both studies, the patients who were given Calquence experienced longer progress-free survival.
Some side effects occurred including anemia, neutropenia (low levels of white blood cells); upper respiratory tract infection, thrombocytopenia, headache, diarrhea not to mention musculoskeletal pain. Other experiences included some atrial fibrillation and flutter not to mention irregular heartbeat. See a link to side effects.