China-based biotechnology company BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has accepted for review a new supplemental new drug application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The application seeks to add a new indication for the treatment of adults with relapsed/refractory follicular lymphoma (FL) in combination with Roche’s CD20-targeted Gazyva (obinutuzmab).
Fifth Indication for Brukinsa Under FDA Review
This sNDA marks BeiGene’s fifth indication for Brukinsa that has been accepted by the FDA for review. The regulator has set a target action date in Q1 2024 to complete the review process, which could potentially expand the drug’s usage and accessibility for patients in need.
Supporting Data from Phase II ROSEWOOD Study
The sNDA is supported by data from BeiGene’s Phase II ROSEWOOD study, which demonstrated that the combination of Brukinsa and obinutuzumab outperformed obinutuzumab monotherapy. The study indicated overall response rates of about 68% for the combination therapy and 46% for monotherapy (p = 0.0017), highlighting the potential efficacy of the combined treatment approach.
Global Marketing Applications for Brukinsa
Currently, BeiGene (BGNE) also has marketing applications for Brukinsa in relapsed/refractory FL under review in the European Union and China, indicating the company’s commitment to expanding access to this treatment option on a global scale.-Fineline Info & Tech
