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.