FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients
Portfolio Pulse from Vandana Singh
The FDA's Oncologic Drugs Advisory Committee is set to discuss the use of PD-1 cancer drugs from Merck, Bristol Myers, and BeiGene for certain gastric cancer patients. The FDA has raised concerns about the efficacy of these drugs for patients with low PD-L1 expression, suggesting that they may not benefit and could face severe side effects.
September 25, 2024 | 7:54 pm
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NEGATIVE IMPACT
BeiGene's Tevimbra is under FDA review for its use in gastric cancer patients with low PD-L1 expression. The FDA's concerns about efficacy could impact the drug's approval and market entry.
The FDA's concerns about Tevimbra's efficacy for low PD-L1 expression patients could delay approval and limit market entry, negatively impacting BeiGene's stock.
CONFIDENCE 85
IMPORTANCE 60
RELEVANCE 70
NEGATIVE IMPACT
Bristol Myers' Opdivo and Yervoy are under FDA review for their efficacy in treating gastric cancer patients with low PD-L1 expression. The FDA suggests these patients may not benefit from the drugs, raising concerns about their use.
The FDA's concerns about the efficacy of Opdivo and Yervoy for patients with low PD-L1 expression could lead to reduced usage and potential regulatory restrictions, negatively impacting Bristol Myers' stock.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
Merck's Keytruda is being reviewed by the FDA for its effectiveness in gastric cancer patients with low PD-L1 expression. The FDA indicates these patients may not benefit, which could affect the drug's market potential.
The FDA's doubts about Keytruda's efficacy for low PD-L1 expression patients could lead to decreased prescriptions and market share, negatively affecting Merck's stock.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80