FDA Approves Calquence for Leukemia and Lymphoma Subsets

In partnership with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the Food and Drug Administration (FDA) has granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

While both diseases are cancers of the lymphocytes, CLL occurs in the blood and bone marrow and SLL most often occurs in the lymph nodes. This approval, a result of the Project Orbis partnership between the FDA, TGA and Health Canada, now offers patients with these diseases a new treatment option as either an initial or subsequent therapy.

“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” said Dr. 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.”

The approval was based on the results of two clinical trials, involving a combined total of more than 800 patients with CLL — 535 previously untreated and 310 previously treated – all of whom saw longer progression-free survival than patients who received other standard treatments.

Common side effects include anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea and musculoskeletal pain. Females of reproductive age are recommended to use effective contraception during treatment with Calquence, as it may cause harm to a developing fetus or newborn baby, or cause delivery complications.

Check back later to learn more about how this approval will affect patients with CLL and SLL.