BeiGene (BGNE) Announces FDA Acceptance of sNDA for Fifth BRUKINSA Indication streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
BeiGene, Ltd. (BGNE), a clinical-stage pharmaceutical company, announced Wednesday that the U.S. Food and Drug Administration has accepted for review its supplemental new drug application or sNDA for BRUKINSA (zanubrutinib) in combination with obinutuzumab as a treatment for relapsed or refractory follicular lymphoma.
The FDA has accepted a supplemental biologics license application seeking the approval of zanubrutinib in combination with obinutuzumab in the treatment of adult patients with relapsed/refractory follicular lymphoma who received at least 2 prior lines of therapy.
The Food and Drug Administration accepted a supplemental New Drug Application for Brukinsa plus Gazyva to treat patients with relapsed or refractory follicular lymphoma.
Following positive phase 2 results from the ROSEWOOD study, BeiGene is seeking FDA approval of zanubrutinib plus obinutuzumab for select patients with relapsed/refractory (R/R) follicular lymphoma.