BeiGene’s BRUKINSA gains accelerated FDA approval for follicular lymphoma treatment

In a significant development for patients with relapsed or refractory follicular lymphoma, BeiGene, Ltd. has announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA (zanubrutinib). This marks the treatment as the first and only BTK inhibitor approved for adult patients in the U.S. who have undergone two or more lines of systemic therapy. The approval, emphasizing the treatment’s efficacy and the durability of response, extends BRUKINSA’s indications within B-cell malignancies, highlighting its broadened application and distinct clinical profile in oncology globally.

Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene, lauded the approval, noting BRUKINSA’s unique position in addressing a critical need for follicular lymphoma patients. This endorsement not only underscores the drug’s differentiated efficacy but also strengthens BeiGene’s commitment to pioneering in the oncology landscape.

The FDA’s decision is rooted in data from the ROSEWOOD trial, which demonstrated a notable improvement in overall response rates when BRUKINSA was combined with the anti-CD20 monoclonal antibody obinutuzumab, compared to obinutuzumab alone. The ongoing MAHOGANY trial is expected to further validate these findings, reinforcing the potential for continued approval based on comprehensive clinical benefits.

Christopher Flowers, M.D., from The University of Texas MD Anderson Cancer Center, highlighted the significance of the ROSEWOOD trial findings. He emphasized the clinical advantage of the zanubrutinib and obinutuzumab combination for patients experiencing relapse or refractory follicular lymphoma. This sentiment is echoed by the Follicular Lymphoma Foundation, which recognized the promising impact of novel treatments like BRUKINSA on advanced follicular lymphoma care.

BRUKINSA’s approval for R/R follicular lymphoma enriches its portfolio, which already includes indications for Waldenström’s macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma. Its proven efficacy, particularly demonstrated in the ALPINE trial against ibrutinib in chronic lymphocytic leukemia, underscores its potential to offer sustained progression-free survival benefits across various patient subgroups, including those with high-risk genetic profiles.

Globally, BRUKINSA has received approval in 70 markets, including major regions such as the U.S., EU, Great Britain, Canada, Australia, China, South Korea, and Switzerland for selected indications. The expansive development program for BRUKINSA, involving over 5,000 subjects in 29 countries, indicates BeiGene’s dedication to broadening the drug’s accessibility and impact on cancer treatment worldwide. Follicular lymphoma, as the second most common type of non-Hodgkin lymphoma, poses a significant burden, with approximately 15,000 cases diagnosed annually in the U.S. alone. Although the condition remains incurable, advancements in treatment such as BRUKINSA offer hope for extended survival and improved quality of life for patients.

BRUKINSA’s approval is a testament to its unique mechanism of action, targeting Bruton’s tyrosine kinase (BTK) with optimized bioavailability, half-life, and selectivity. This enables sustained inhibition of malignant B cell proliferation, offering a new lease on life for patients with advanced follicular lymphoma.

This development is not just a win for BeiGene but a beacon of hope for the broader oncology community, demonstrating the potential of targeted therapies in managing complex malignancies. As the landscape of cancer treatment continues to evolve, BRUKINSA’s role in it becomes increasingly significant, reflecting the progress in precision medicine and the ongoing commitment to addressing unmet medical needs.

The accelerated approval of BRUKINSA by the FDA marks a pivotal milestone in the treatment of relapsed or refractory follicular lymphoma. Its demonstrated efficacy and safety profile, supported by robust clinical trial data, signify a critical advancement in the management of this challenging condition. As we await further outcomes from the confirmatory MAHOGANY trial, the current evidence positions BRUKINSA as a cornerstone therapy, potentially altering the treatment paradigm for follicular lymphoma and reinforcing the value of targeted therapeutic approaches in oncology.