Posted by Michael Wonder on 12 Jul 2023
BeiGene announces FDA acceptance of sNDA for fifth Brukinsa indication
12 July 2023 - Submission seeks approval for Brukinsa in combination with obinutuzumab as a treatment for relapsed or refractory follicular lymphoma.
BeiGene today announced the US FDA has accepted for review the Company’s supplemental new drug application for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior lines of therapy.
