BeiGene’s Brukinsa (zanubrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma.

The BTK inhibitor has specifically been authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy.

The FDA’s decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone.

An 18-month duration of response of 69% for the Brukinsa combination was also observed, BeiGene said, adding that safety results were consistent with previous studies of both medicines.

Mehrdad Mobasher, chief medical officer, haematology at BeiGene, said: “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.”

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma, with approximately 15,000 new cases of the disease diagnosed in the US every year.

While the disease is incurable, BeiGene noted that it has a five-year survival rate of around 90% and that approximately half of patients live for nearly two decades.

“Follicular lymphoma can significantly impact patients’ lives and prove to be challenging, especially for those whose condition has advanced despite undergoing prior treatment or experienced relapse,” the Follicular Lymphoma Foundation outlined.

The foundation added that the emergence of new treatment options which have been shown to be effective and well-tolerated, including the Brukinsa regimen, “brings hope” to patients with advanced disease.

Beyond follicular lymphoma, Brukinsa has been approved in the US to treat certain patients with Waldenström’s macroglobulinaemia, mantle cell lymphoma, marginal zone lymphoma and, most recently, chronic lymphocytic leukaemia or small lymphocytic lymphoma.

Mobasher said: “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.”

https://pmlive.com/pharma_news/beigenes-brukinsa-granted-fda-accelerated-approval-for-advanced-follicular-lymphoma/