FDA Approval Insights: Zanubrutinib in CLL and SLL


Drs Flinn, Lamanna, Brown, and Tam discuss the FDA approval of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Ian Flinn, MD, PhD; Nicole Lamanna, MD; Jennifer R. Brown, MD, PhD; and Constantine Tam, MD, MBBS, about the FDA approval of zanubrutinib (Brukinsa) in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Dr Flinn is the director of Lymphoma Research at Sarah Cannon Research Institute at Tennessee Oncology and the director of the Sarah Cannon Transplant and Cellular Therapy Program at TriStar Centennial in Nashville. Dr Lamanna is an associate clinical professor of medicine in the Hematologic Malignancies Section of the Hematology/Oncology Division at the Columbia University Herbert Irving Comprehensive Cancer Center in New York, New York. Dr Brown is the director of the Chronic Lymphocytic Leukemia Center at Dana-Farber Cancer Institute and the Worthington and Margaret Collette Professor of Medicine in the Field of Hematologic Oncology at Harvard Medical School in Boston, Massachusetts. Dr Tam is the head of the Lymphoma Service and a clinical hematologist at Alfred Health, as well as a professor of hematology at Monash University in Melbourne, Australia.

On January 19, 2023, the FDA approved zanubrutinib for patients with CLL or SLL, based on findings from the phase 3 SEQUOIA trial (NCT03336333) in patients with treatment-naïve disease and findings from the phase 3 ALPINE trial (NCT03734016) in patients with relapsed/refractory disease. In SEQUOIA, treatment with zanubrutinib led to a median progression-free survival (PFS) that was not reached vs 33.7 months with bendamustine and rituximab (Rituxan; BR) in a randomized cohort. The overall response rate (ORR) was 94.6% with zanubrutinib vs 85.3% with BR. In ALPINE, median PFS was not reached in patients who received zanubrutinib vs 34.2 months with ibrutinib (Imbruvica). The ORRs with zanubrutinib and ibrutinib were 83.5% and 74.2%, respectively.

In our exclusive interview, Dr Flinn discussed the significance of this approval and how it addresses previously unmet needs in CLL/SLL, Drs Brown and Tam highlighted key efficacy and safety data from the ALPINE and SEQUOIA trials, and Dr Lamanna explained the unique mechanism of action of zanubrutinib and where this agent may fit into the treatment paradigm.


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