FDA Conditionally Approves Expanded Use Of BeiGene's Combination Drug For Certain Type Of Blood Cancer
Portfolio Pulse from Vandana Singh
The FDA granted accelerated approval to BeiGene Ltd's Brukinsa, in combination with Roche Holdings AG's Gazyva, for adult patients with relapsed or refractory follicular lymphoma, marking its fifth indication in the U.S. This approval is based on the response rate and durability from the ROSEWOOD Phase 2 trial. Brukinsa's global sales reached $1.3 billion for the full year 2023, with peak annual sales estimated to be $3 billion to $4 billion. BGNE shares rose 0.94% following the announcement.
March 08, 2024 | 3:02 pm
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NEGATIVE IMPACT
AbbVie's Imbruvica, being in the same class of drugs as Brukinsa, may face increased competition following Brukinsa's latest FDA approval.
Brukinsa's approval for an additional indication increases its competitive stance against similar drugs like AbbVie's Imbruvica, potentially impacting Imbruvica's market share.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 60
NEGATIVE IMPACT
Gilead Sciences' Yescarta, as an alternative treatment option for follicular lymphoma, may encounter heightened competition due to Brukinsa's expanded approval.
The FDA's approval of Brukinsa for an additional indication introduces more competition for Gilead Sciences' Yescarta, potentially affecting its position in the treatment landscape for follicular lymphoma.
CONFIDENCE 75
IMPORTANCE 65
RELEVANCE 50
NEGATIVE IMPACT
Novartis' Kymriah, another treatment option for follicular lymphoma, might see increased competition from Brukinsa's new FDA approval.
With Brukinsa receiving FDA approval for an additional indication, Novartis' Kymriah could experience increased competition in the market for follicular lymphoma treatments.
CONFIDENCE 75
IMPORTANCE 65
RELEVANCE 50
POSITIVE IMPACT
BeiGene's Brukinsa received FDA accelerated approval for a new indication, potentially boosting its market presence and contributing to its strong sales growth.
The FDA's accelerated approval of Brukinsa for a new indication directly impacts BeiGene by potentially increasing the drug's market share and contributing to its revenue growth, as reflected in the positive stock price movement.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100
POSITIVE IMPACT
Roche Holdings AG's Gazyva is part of the combination therapy with BeiGene's Brukinsa that received FDA accelerated approval, potentially increasing its usage and visibility in the treatment of follicular lymphoma.
The combination therapy involving Roche's Gazyva and BeiGene's Brukinsa for follicular lymphoma has received FDA approval, which could lead to increased usage and visibility for Gazyva in this treatment area.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80