FDA accepts sNDA for Brukinsa + obinutuzumab indication for r/r/ follicular lymphoma after two prior therapies
BeiGene announced the FDA has accepted for review the Company’s supplemental new drug application (sNDA) for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy
Brukinsa was previously granted Fast Track and Orphan designation for this indication. The FDA has assigned a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act.
BeiGene currently has submissions for Brukinsa in R/R FL under review by regulatory authorities in the European Union and China. BeiGene’s submission for Brukinsa in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom as part of the Access Consortium New Active Substance Work-sharing Initiative.
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