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New Hope for Follicular Lymphoma Patients: FDA Grants Accelerated Approval to Brukinsa

FDA & EMA

8 March 2024

The FDA has granted accelerated approval to Brukinsa (zanubrutinib) in combination with obinutuzumab for treating relapsed or refractory follicular lymphoma. This marks the first approval of a BTK inhibitor for this condition, offering new hope to patients after unsuccessful systemic therapies.

BeiGene, a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Brukinsa® (zanubrutinib) in combination with obinutuzumab for the treatment of relapsed or refractory follicular lymphoma. Brukinsa® demonstrates significant improvements in response rates (ORR 69%) and treatment durability, especially for adult patients who have not responded to at least two lines of systemic therapy.

“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. 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,” said Dr. Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene.

Brukinsa, a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), stands out as the first and only BTK inhibitor approved for this indication. This groundbreaking decision is based on the positive results of the ROSEWOOD trial, showcasing a higher overall response rate when used in combination with obinutuzumab compared to obinutuzumab alone.

The ROSEWOOD trial, is a global, randomized, open-label Phase 2 study, demonstrated the efficacy and safety of Brukinsa in a challenging patient population. With an overall response rate of 69% in the Brukinsa plus obinutuzumab arm, compared to 46% in the obinutuzumab alone arm, the evidence was compelling. Furthermore, the durability of response, a critical factor in cancer treatment, was evident with a landmark 18-month duration of response rate of 69%.

Dr. Christopher Flowers, Chair of the Department of Lymphoma Texas MD Anderson Cancer Center commented, “Patients living with follicular lymphoma often experience relapse or do not respond to treatment and need options for treatment during the course of their illness. The findings from the ROSEWOOD trial highlight the significant clinical advantage of treating patients who experience relapse or have refractory follicular lymphoma with zanubrutinib plus obinutuzumab.”

The accelerated approval of Brukinsa for the treatment of relapsed or refractory follicular lymphoma is more than just a new treatment option; it represents a significant leap forward in the relentless fight against malignancies, bringing new hope to patients and their families.

About Follicular lymphoma

Follicular lymphoma, a subtype of non-Hodgkin lymphoma, is the second most prevalent form of the disease, accounting for about 22% of all cases. However, with a five-year survival rate of about 90%, and many living nearly two decades post-diagnosis, the focus has shifted towards finding effective treatments for relapsed or refractory cases.

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