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FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma


BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

Image credit: Lisa | stock.adobe.com. High grade follicular lymphoma with marginal zone differentiation. Multiple lymphocytes are undergoing mitosis. Microscopic view.

Image credit: Lisa | stock.adobe.com

The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1

Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy followed by Gazyva monotherapy in patients with stage II bulky, III, or IV FL; and combined with (Bendeka) bendamustine followed by Gazyva monotherapy for FL in adults who did not respond to a rituximab-containing regimen, or whose FL returned.3

“This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not responded to initial therapies or have experienced relapse,” Mehrdad Mobasher, MD, MPH, chief medical officer, Hematology at BeiGene, said in a press release. “Brukinsa is the only BTK inhibitor to date that shows efficacy with this type of malignancy and now has the broadest label, including five oncology indications, of any medication in its class globally. This is a testament to Brukinsa’s differentiated clinical profile and our continued commitment to bringing this much-needed treatment option to patients around the world.”1

The FDA based the accelerated approval on findings from the global, randomized, open-label Phase II ROSEWOOD trial (NCT03332017). Investigators enrolled patients with grade 1 to 3a relapsed/refractory FL previously administered at least two lines of therapy, including an anti-CD20 antibody and an alkylating agent. Patients were randomly assigned 2:1 to receive oral Brukinsa at 160 mg twice daily plus Gazyva or Gazyva monotherapy. Gazyva was administered at 1000 mg to both cohorts on days one, eight, and 15 of cycle one, then on day one of cycles two to six, and then once every eight weeks up to a maximum of 20 doses.

The trial’s primary endpoint was overall response rate (ORR) per independent review committee (IRC) assessment, with secondary endpoints of IRC-assessed duration of response (DOR), progression-free survival (PFS), overall survival (OS), time to next treatment, and safety.

At a median follow-up of 20.2 months, the Brukinsa combination produced an ORR of 69% (n = 145) compared with 46% in the Gazyva monotherapy cohort (n = 72). The complete response rate in the Brukinsa combination cohort was 39.3% compared with 19.4% in the Gazyva monotherapy cohort. DOR was 69% at the 18-month landmark in the Brukinsa combination cohort.1

Median PFS was 28.0 months in the Brukinsa combination cohort compared with 10.4 months with Gazyva monotherapy. Median OS was not evaluable with the combination compared to 34.6 months the monotherapy cohort, with 24-month OS rates of 77.3% for the Brukinsa combination vs. 71.4% for Gazyva monotherapy.4

In terms of safety, the most common treatment-emergent adverse effects were diarrhea (Brukinsa/Gazyva, 18.2%; Gazyva, 16.9%), fatigue (15.4%; 14.1%), pyrexia (13.3%; 19.7%), constipation (13.3%; 8.5%), cough (12.6%; 12.7%), asthenia (11.9%; 8.5%), pneumonia (11.9%; 7%), dyspnea (11.2%; 9.9%), back pain (11.5%; 5.6%), COVID-19 (9.8%; 9.9%), nausea (9.1%; 14.1%), abdominal pain (7.7%; 11.3%), pruritis (7%; 9.9%), and infusion-related reaction (2.8%; 9.9%).4


1. BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma. BeiGene. March 7, 2024. Accessed March 8, 2024. https://ir.beigene.com/news/beigene-announces-fda-accelerated-approval-of-brukinsa-for-the-treatment-of-relapsed-or-refractory-follicular/0ae1ffae-3b3c-4df4-99f8-3507c95a352f/

2. U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma. News release. BeiGene, Ltd; September 15, 2021. Accessed March 8, 2024. https://ir.beigene.com/news-details/?id=0d5b56bb-d6cd-4606-a9bd-f49e85bb113b

3. Gazyva. Prescribing information. Roche; Accessed March 8, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf

4. Flowers C, Zinzani PL, Mayer J, et al. Zanubrutinib plus obinutuzumab versus obinutuzumab in patients with relapsed/refractory follicular lymphoma: Updated analysis of the ROSEWOOD study. J Clin Oncol. 2023;41(suppl 16):7545. doi:10.1200/JCO.2023.41.16_suppl.7545. Accessed March 8, 2024.

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