FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis

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On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for acalabrutinib provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

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“Today, as part of an [American], Australian, and Canadian collaboration known as Project Orbis, the U.S. approved a new treatment option for those living with CLL or SLL. 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 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 supplemental approval of acalabrutinib was based on two randomized, phase III clinical trials that compared the drug to other standard treatments.

The first clinical trial—ELEVATE-TN—involved 535 patients with previously untreated CLL and evaluated the efficacy of obinutuzumab in combination with chlorambucil compared with acalabrutinib in combination with obinutuzumab. Patients receiving acalabrutinib had a longer progression-free survival vs patients on the other regimen.

The second clinical trial—ASCEND—included 310 patients with previously treated CLL, and evaluated the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine. Patients receiving acalabrutinib also had a longer progression-free survival than patients receiving other standard treatments.

The most common side effects of acalabrutinib were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

Patients may experience:

  • Atrial fibrillation and flutter, and should be monitored for symptoms of arrhythmias
  • Serious infections, and should be monitored and treated promptly
  • Bleeding, and should be monitored and managed appropriately
  • Low blood counts, and should have blood work monitored regularly.

Patients should be advised to use sun protection, as other malignancies—such as skin cancers and other solid tumors—have occurred in patients taking acalabrutinib.

In addition to the international collaboration with Australia and Canada, this review used the Real-Time Oncology Review (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application. RTOR, and its accompanying Assessment Aid, facilitated discussions among the regulatory agencies. These applications were approved 4 months prior to the FDA goal date.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.