On November 21, 2019, the FDA approved acalabrutinib (Calquence; AstraZeneca) as initial or subsequent therapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is the second approval under Project Orbis, a collaboration between the FDA, the Australian Therapeutic Goods Administration, and Health Canada.
“Today, as part of a US, Australian, and Canadian collaboration known as Project Orbis, the US 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,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “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 also used the Real-Time Oncology Review pilot program when it reviewed the application for acalabrutinib, a process designed to streamline the submission of data before the completion of the entire drug application.
The agency based its supplemental approval on data from the interim analyses of 2 phase 3 randomized clinical trials (ELEVATE-TN and ASCEND) that compared acalabrutinib as monotherapy or in combination with obinutuzumab in patients with CLL. In both trials, progression-free survival was longer with alabrutinib treatment versus other standard therapies.
The most common (≥20%) adverse events associated with acalabrutinib include anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, bruising, and myalgia.