European Commission Approves Zanubrutinib for CLL

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

The approval is based on positive findings 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 with 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 elicit improved outcomes vs ibrutinib in relapsed/refractory CLL, having demonstrated an independent review committee–assessed overall response rate (ORR) of 80.4% vs 72.9%, respectively (P = .0264). Additionally, more patients treated with zanubrutinib than ibrutinib had a sustained response at 1 year, at 90% vs 78%, respectively.

Following the regulatory submission, BeiGene announced topline results of the final progression-free survival (PFS) analysis of the ALPINE trial, in which zanubrutinib also demonstrated improved PFS compared with 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 press release. “Given that zanubrutinib has demonstrated consistent benefit across patient subgroups, regardless of risk status, we believe zanubrutinib could now be the preferred treatment option for newly diagnosed and relapsed/refractory CLL patients.”

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 has demonstrated clinically meaningful improvements as a next-generation BTK inhibitor over the first-generation BTK inhibitor and is proven to be significantly more effective and tolerable. Ensuring medicines 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 offers a practice-changing option for patients with CLL, one of the most common types of leukemia in adults,” Clemens Wendtner, MD, head of Hematology and Oncology at Munich Clinic, an academic teaching hospital of the University of Munich in Germany, added.

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

“We’re pleased with the significant progress we’ve made to date bringing zanubrutinib to patients with hematological malignancies globally,” Gerwin Winter, senior vice president and head of Europe at BeiGene, said. “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.”

References

1. BeiGene receives European Commission approval for BRUKINSA® (zanubrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). News release. BeiGene. November 17, 2022. Accessed November 18, 2022. https://bit.ly/3gl1Cpq
2. BeiGene announces US FDA acceptance of supplemental new drug application for BRUKINSA (zanubrutinib) in chronic lymphocytic leukemia. News release. BeiGene; February 22, 2022. Accessed November 18, 2022. https://bit.ly/3s7MBKx