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FDA approves Calquence for chronic lymphocytic leukemia under international collaboration
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The FDA today approved acalabrutinib as initial or subsequent therapy for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.
This marks the second approval under Project Orbis, a collaboration between the FDA and Australian Therapeutic Goods Administration and Health Canada. FDA also used the Real-Time Oncology Review pilot program in its review of the application for acalabrutinib (Calquence, AstraZeneca), a process that is meant to streamline the submission of data before the completion of the entire drug application.
“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 chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” 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, said in a press release. “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 FDA based this supplemental approval of acalabrutinib on data from two randomized studies. The first trial — which included 535 patients with previously untreated CLL — showed longer PFS among patients assigned acalabrutinib compared with other standard treatments.
The second trial of 310 patients with CLL also showed longer PFS with acalabrutinib vs. other standard treatments.
Common adverse events associated with acalabrutinib included anemia, neutropenia, upper respiratory tract infection, thrombocytopenia headache, diarrhea and musculoskeletal pain.
This application previously received breakthrough therapy designation and priority review.