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Beigene's Zanubrutinib (BGB-3111) Receives the US FDA's Breakthrough Therapy Designation for Mantle Cell Lymphoma (MCL)

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Beigene's Zanubrutinib (BGB-3111) Receives the US FDA's Breakthrough Therapy Designation for Mantle Cell Lymphoma (MCL)

Shots:
  • The BT designation follows the P-II trial assessing Zanubrutinib in patients with 1L mantle cell lymphoma
  • Beigene’s Zanubrutinib is being evaluated globally in seven P-III trials in multiple areas including one for patients with waldenstrom macroglobulinemia (WM) with zanubrutinib vs ibrutinib and P-II for r/r follicular lymphoma in combination with Gazyva (obinutuzumab)
  • Zanubrutinib (BGB-3111) is a Bruton’s tyrosine kinase (BTK) inhibitor and has also received NMPA’s (CMPA) priority review for r/r MCL and r/ r CLL/SLL in China
Ref: Globe News Wire | Image: Twitter

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