FDA Grants Accelerated Approval to BeiGene’s Brukinsa (zanubrutinib) + Obinutuzumab for Relapsed or Refractory Follicular Lymphoma (FL)

On Mar. 7, 2024, US FDA granted accelerated approval to zanubrutinib in combination with obinutuzumab for relapsed or refractory follicular lymphoma (r/r FL) after 2+ lines of systemic therapy.

Zanubrutinib has been approved across 5 oncology indications:

·         r/r FL

·         mantle cell lymphoma

·         marginal zone lymphoma

·         chronic lymphocytic leukemia or small lymphocytic lymphoma

·         Waldenström’s macroglobulinemia

Of note:

This application used Assessment Aid and was granted:

·         Fast Track Designation

·         Orphan Drug Designation

Link to FDA approval announcement

Link to product label

Link to Press Release