Prodotti competitors / Area Kite
FDA Grants Accelerated Approval to BeiGene’s Brukinsa (zanubrutinib) + Obinutuzumab for Relapsed or Refractory Follicular Lymphoma (FL)
![Immagine News](/media/l4el5htd/cat-2.jpg?anchor=center&mode=crop&width=722&height=442)
On Mar. 7, 2024, US FDA granted accelerated approval to zanubrutinib in combination with obinutuzumab for relapsed or refractory follicular lymphoma (r/r FL) after 2+ lines of systemic therapy.
Zanubrutinib has been approved across 5 oncology indications:
· r/r FL
· mantle cell lymphoma
· marginal zone lymphoma
· chronic lymphocytic leukemia or small lymphocytic lymphoma
· Waldenström’s macroglobulinemia
Of note:
This application used Assessment Aid and was granted:
· Fast Track Designation
· Orphan Drug Designation
Link to FDA approval announcement
Link to product label
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