The FDA Approved Label Update For Beigene's Brukinsa (Zanubrutinib) To Include Progression Free Survival From Phase 3 ALPINE Trial Comparing Brukinsa Vs. Imbruvica (Ibrutinib) In Previously Treated Relapsed/Refractory Chronic Lymphocytic Leukemia Patients
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The FDA has approved an update to the label for BeiGene's Brukinsa (Zanubrutinib) to include progression-free survival data from the Phase 3 ALPINE trial. This trial compared Brukinsa to Imbruvica (Ibrutinib) in previously treated relapsed/refractory chronic lymphocytic leukemia patients.
December 22, 2023 | 11:04 am
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POSITIVE IMPACT
BeiGene's Brukinsa label update by the FDA, including positive Phase 3 trial results, could boost investor confidence and potentially increase the drug's market share against competitors like Imbruvica.
The FDA's approval of the label update for Brukinsa is a significant regulatory milestone for BeiGene, likely to enhance the drug's credibility and marketability. Positive trial results directly comparing Brukinsa to a competitor can influence doctors' prescribing decisions and improve sales. This news is highly relevant and important to BeiGene and could positively impact its stock price in the short term.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 90