Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy

1. FDA Approves Brukinsa: The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Brukinsa (zanubrutinib) in combination with obinutuzumab for treating relapsed or refractory follicular lymphoma (FL).

2. First BTK Inhibitor for FL: Brukinsa becomes the first Bruton's tyrosine kinase (BTK) inhibitor authorized for FL treatment, offering a novel therapeutic option for patients whose condition has advanced despite previous treatments or experienced relapses.

3. CHMP Positive Opinion: The Committee for Medicinal Products for Human Use (CHMP) recommended Brukinsa plus obinutuzumab for follicular lymphoma, potentially becoming the first medicine of this type approved for four indications in the European Union.

4. Clinical Data Support: The approval is based on positive results from the ROSEWOOD Phase II study and supported by the Phase Ib BGB-3111-GA101-001 study. The overall response rate (ORR) in the Brukinsa plus obinutuzumab arm was 69.0%, compared to 45.8% for patients treated with obinutuzumab alone.

5. Broadest Label: With this approval, Brukinsa now has the broadest label among BTK inhibitors, with five oncology indications.

6. Follicular Lymphoma: FL is the second most common type of non-Hodgkin lymphoma, accounting for 22% of all non-Hodgkin lymphoma cases.