BeiGene's Brukinsa Approved By Health Canada For Treating Follicular Lymphoma

(RTTNews) - BeiGene, Ltd. (BGNE) announced on Wednesday that Health Canada has authorized the use of Brukinsa or zanubrutinib in combination with obinutuzumab for treating adult patients with relapsed follicular lymphoma or FL, who have undergone at least two prior systemic therapies.

The company said that the approval in Canada is based on the positive findings from the Rosewood Phase 2 study, which compared the highly selective Bruton's tyrosine kinase inhibitor Brukinsa in conjunction with obinutuzumab versus obinutuzumab alone.

Sarit Assouline, a Hematologist at McGill University stated, "The approval of Brukinsa is a significant development offering proven clinical benefits and presenting a chemotherapy-free oral treatment option for eligible patients with relapsed or refractory follicular lymphoma."

This approval represents the fifth hematology indication for Brukinsa in Canada.