New Calquence Indication Approved

As part of the Project Orbis collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA has granted supplemental approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. An agency statement says Project Orbis provides a framework for concurrent submission and review of oncology drug applications among FDA’s international partners.

The new Calquence indication was based on two trials that compared the drug to other standard treatment. Most common Calquence side effects were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

The statement says that in addition to the international collaboration with Australia and Canada, the Calquence review used the real-time oncology review pilot program that can streamline the submission of data prior to the completion and submission of the entire clinical application.