European Commission approves zanubrutinib for CLL

The European Commission has approved zanubrutinib for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia.

The European Commission has approved zanubrutinib (Brukinsa) for the treatment of treatment-naïve or relapsed/refractory adult patients with chronic lymphocytic leukemia (CLL).1

The approval is based on positive results from the Phase 3 SEQUOIA (NCT03336333) and ALPINE (NCT03734016) trials in patients with previously untreated and relapsed/refractory CLL, respectively. In both trials, zanubrutinib demonstrated improved efficacy compared to bendamustine plus rituximab (Rituxan; BR) and ibrutinib (Imbruvica) in patients with previously untreated and relapsed/refractory CLL, respectively.

Zanubrutinib is the only BTK inhibitor to show improved outcomes over ibrutinib in relapsed/refractory CLL, having demonstrated an Independent Review Board Assessed Overall Response Rate (ORR) of 80.4% versus 72.9%, respectively (P = 0.0264). Additionally, more patients treated with zanubrutinib than ibrutinib had a sustained response at 1 year, at 90% versus 78%, respectively.

Following the regulatory submission, BeiGene announced the first results of the final analysis of progression-free survival (PFS) from the ALPINE trial, in which zanubrutinib also demonstrated improved PFS compared to ibrutinib in patients with relapsed/refractory CLL.

“This approval represents an important milestone for CLL patients and their physicians who now have a new chemotherapy-free treatment option and an alternative to current BTK inhibitor treatment options,” Mehrdad Mobasher, MD, MPH, chief medical officer of hematology at BeiGene, said in a statement. “Given that zanubrutinib demonstrated consistent benefits across all patient subgroups, regardless of risk status, we believe that zanubrutinib may now be the preferred treatment option for patients with newly diagnosed CLL. and relapsed/refractory.”

On February 23, 2022, the FDA accepted for review a supplemental new drug application for zanubrutinib for the treatment of adult patients with CLL or small lymphocytic lymphoma.2

“Zanubrutinib demonstrated clinically meaningful improvements as a next-generation BTK inhibitor compared to the first-generation BTK inhibitor and was found to be significantly more efficacious and tolerable. Ensuring that medications are safe and tolerable for this patient population is critical given the long-term treatment needed for CLL. Combined with the flexible dosing options, this approval provides a practice change option for patients with CLL, one of the most common types of leukemia in adults,” said Clemens Wendtner, MD, head of the hematology and oncology at the Munich Clinic, a university teaching hospital. from the University of Munich in Germany, added.

Regarding safety, adverse effects in SEQUOIA and ALPINE were consistent with the overall safety profile of zanubrutinib.

“We are pleased with the significant progress we have made to date in bringing zanubrutinib to patients with hematological malignancies around the world,” said Gerwin Winter, senior vice president and head of Europe at BeiGene. “With this notable approval, we welcome the opportunity to expand BeiGene’s presence in Europe and provide this innovative treatment option to CLL patients across the region.”


  1. BeiGene receives European Commission approval for BRUKINSA® (zanubrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). Press release. BeiGene. November 17, 2022. Accessed November 18, 2022.
  2. BeiGene Announces US FDA Acceptance of Supplemental New Drug Application for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia. Press release. BeiGene; February 22, 2022. Accessed November 18, 2022.

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