FDA Approves Acalabrutinib for CLL Indication


Under a new international collaboration, the FDA has granted supplemental approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia.

As part of a new international collaboration, officials with the FDA today granted supplemental approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), according to a press release.1

Project Orbis, a collaboration between the United States, Australia, and Canada, provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners. This is the second action taken by the FDA under the collaboration.1

Acalabrutinib, a Bruton tyrosine kinase inhibitor, is also approved for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.

Approval of the new indication was based on 2 clinical trials comparing acalabrutinib with other standard treatments: the phase 3 ELEVATE-TN and phase 3 ASCEND trials.1 The first trial included 535 patients with previously-untreated CLL who were randomized into 3 treatments arms: chlorambucil plus obinutuzumab, acalabrutinib 100 mg twice daily plus obinutuzumab, and acalabrutinib 100 mg twice daily monotherapy. The trial met is primary endpoint; acalabrutinib in combination with obinutuzumab demonstrated a statistically significant and clinically meaningful improvement in profession-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab, according to the study.2

In the second trial, 310 patients were randomized into 2 treatment groups: acalabrutinib 100 mg twice daily monotherapy and rituximab plus physician’s choice of idelalisib or bendamustine. Results showed a statistically significant and clinically meaningful improvement in PFS with acalabrutinib monotherapy compared with the second treatment group.3

Across both studies, the safety and tolerability of acalabrutinib was consistent with the known profile. The most common adverse effects observed were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.1

Additionally, full data from the ELEVATE-TN clinical trial will be presented at the upcoming American Society of Hematology Annual Meeting and Exposition.2

The FDA previously granted this application Priority Review and Breakthrough Therapy designation. Additionally, review for the application also used the Real-Time Oncology Review pilot program, which streamlines the submission of data prior to the completion and submission of the entire clinical application, according to the FDA.1

Acalabrutinib is currently being evaluated for the treatment of multiple B-cell cancers, including CLL, diffuse large B-cell lymphoma, Waldenstrom macroglobulinemia, follicular lymphoma, multiple myeloma, and other hematologic malignancies.1


  • FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-takes-second-action-under-international-collaboration-approves-new-treatment-option-patients. Accessed November 21, 2019.
  • Calquence Phase III ELEVATE-TN trial met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukemia [news release]. AstraZeneca’s website. https://www.astrazeneca.com/media-centre/press-releases/2019/calquence-phase-iii-elevate-tn-trial-met-primary-endpoint-at-interim-analysis-in-previously-untreated-chronic-lymphocytic-leukaemia06062019.html. Accessed November 21, 2019.
  • Calquence Phase 3 ASCEND trial met primary endpoint at interim analysis in relapsed or refractory chronic lymphocytic leukemia and will stop early [news release]. AstraZeneca’s website. https://www.astrazeneca.com/media-centre/press-releases/2019/calquence-phase-iii-ascend-trial-met-primary-endpoint-at-interim-analysis-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-and-will-stop-early-07052019.html. Accessed November 21, 2019.

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