BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for the Treatment of Waldenström’s Macroglobulinemia

September 2, 2021 Auto Bot approval, BeiGene, FDA, regulatory 0

Shots:

  • The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg, bid, or 320 mg, qd) vs ibrutinib in 201 patients with WM who harbor an MYD88 mutation
  • The 1EPs of the trial was VGPR rate in the overall ITT population as assessed by IRC. VGPR rate (28% vs 19%) based on the modified 6th IWWM-6 & (16% vs 7%) based on the IWWM-6 response criteria; response rate (78% vs 78%); event-free DoR (94% vs 88%) @12mos. The therapy demonstrated safety benefits with improved tolerability
  • Brukinsa is a BTK inhibitor, currently being evaluated in a broad clinical program as a monothx. or in combination with other therapies to treat multiple B cell malignancies

Click here to­ read full press release/ article | Ref: Businesswire | Image: BeiGene

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