FDA grants accelerated approval to Brukinsa for advanced follicular lymphoma
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The FDA granted accelerated approval to zanubrutinib in combination with obinutuzumab for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, according to a press release.
Zanubrutinib (Brukinsa, BeiGene) is a Bruton tyrosine kinase inhibitor approved for use in several other B-cell malignancies. The application for this indication received fast track and orphan drug designation.
The agency based the approval on the results of the randomized Study BGB-3111-212 that assessed zanubrutinib plus obinutuzumab (Gazyva, Genentech) in adults with relapsed or refractory advanced follicular lymphoma who had received at least two prior lines of systemic treatment.
Researchers randomly assigned 217 adults in a 2:1 ratio to receive obinutuzumab with or without zanubrutinib. Patients who received zanubrutinib received 160 mg orally twice daily until disease progression or unacceptable toxicity.
Results showed an overall response rate of 69% (95% CI, 61-76) in the investigative arm and 46% (95% CI, 34-58) in the obinutuzumab arm. Study investigators reported an estimated duration of response rate at 18 months of 69% (95% CI, 58-78) in the investigative arm and an actual median duration of response of 14 months (95% CI, 9.2-25.1) in the obinutuzumab monotherapy arm.
The most common adverse reactions that occurred in at least 30% of patients included decreased neutrophil counts (51%) and platelet counts (41%), upper respiratory tract infection (38%), hemorrhage (32%) and musculoskeletal pain (31%). Additionally, serious adverse reactions occurred in 35% of patients who received zanubrutinib.
The recommended zanubrutinib dose is 160 mg orally twice daily or 320 mg taken orally once daily, until either disease progression or unacceptable toxicity.
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