European Heath Agency's Committee Backs Approving BeiGene's Brukinsa In Leukemia Setting

  • European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of BeiGene Limited's BGNE Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) in adults.
  • The CHMP recommendation is based on two global head-to-head Phase 3 clinical trials in which Brukinsa demonstrated superior efficacy - ALPINE comparing Brukinsa to ibrutinib in patients with R/R CLL and SEQUOIA comparing Brukinsa to BR in patients with TN CLL. 
  • Also Read: BeiGene's Brukinsa Shows Superior Progression-Free Survival Versus JNJ's Treatment.
  • "Brukinsa was designed to overcome limitations in efficacy and safety of first-generation Bruton's Tyrosine Kinase inhibitors (BTKi)."
  • "As a result, Brukinsa became the only BTKi to demonstrate superiority versus ibrutinib in the largest head-to-head BTKi study in relapsed/refractory (R/R) CLL, in addition to demonstrating superior Progression-Free Survival against bendamustine plus rituximab (BR) in treatment-naïve patients regardless of age, co-morbidities, mutation, or risk status," said Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene.
  • Price Action: BGNE shares are up 5% at $159.49 on the last check Friday.
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