AInvest Newsletter
Daily stocks & crypto headlines, free to your inbox
GSK's Blenrep Faces FDA Setback Over Eye-Related Side Effects
ByAinvest
Sunday, Jul 20, 2025 7:56 pm ET1min read
GlaxoSmithKline's (GSK) blood cancer drug Blenrep has been recommended against approval by the FDA advisory committee due to concerns about eye-related side effects. The setback comes as GSK focuses on expanding its research and development pipeline to counter declining sales of its top drugs and vaccines. The FDA is set to make a formal decision soon, with analysts suggesting it is unlikely to approve the drug. GSK forecasts peak annual sales of Blenrep to exceed £3 billion ($4 billion).
GlaxoSmithKline's (GSK) blood cancer drug Blenrep has faced a setback after the FDA advisory committee recommended against its approval due to concerns about eye-related side effects. The advisory committee, meeting on Thursday, cited serious eye-related side effects as a primary concern, stating that the risks of the drug outweigh its benefits in treating multiple myeloma [1].The drug, belantamab mafodotin, causes ocular toxicity that is "unique" and not seen with any currently available treatments for multiple myeloma, according to FDA staff reviewers. The reviewers also questioned the company's selected dose, suggesting that lower dosages could offer similar efficacy while reducing the risk of side effects [1].
This recommendation comes at a critical time for GSK, which is focusing on expanding its research and development pipeline to offset declining sales of its top drugs and vaccines. The company's shares fell as much as 7% to 1,315 pence on Friday, making it the biggest loser on the FTSE 100 index [2].
The FDA is expected to make a formal decision on Blenrep by next week. Analysts from Berenberg Bank and JPMorgan suggest that the regulatory body is unlikely to approve the drug, as it typically follows the advisory committee's recommendations [3].
GSK remains confident in Blenrep's benefit-risk profile and plans to continue working closely with the FDA. The company forecasts peak annual sales of the drug to exceed £3 billion ($4 billion). The therapy is currently under review in over 10 countries [3].
References:
[1] https://trial.medpath.com/news/bd736a8ce354f30c/fda-advisory-panel-votes-against-gsk-s-blenrep-for-multiple-myeloma-over-eye-safety-concerns
[2] https://kfgo.com/2025/07/18/gsk-shares-fall-after-blood-cancer-drug-likely-headed-for-u-s-rejection/
[3] https://www.gurufocus.com/news/2986876/gsk-faces-setback-as-fda-advisers-recommend-against-blenrep-approval
Ainvest News articles are AI-generated using advanced large language model (LLM) technology designed to analyze and synthesize publicly available data and news. While AI tools assist in producing initial drafts and insights, all AI generated content published on Ainvest is subject to comprehensive human editorial review before publication. A designated human editor reviews, verifies, and approves each article for factual accuracy, coherence, and compliance with AInvest Fintech Inc’s editorial and disclosure standards.
Despite these review procedures, the information provided may still contain inaccuracies, incomplete data, or time sensitive references due to the inherent limitations of AI generated analysis and evolving changes. The material is provided strictly for informational and educational purposes and does not constitute personalized investment, legal, or financial advice. Readers should independently verify all facts, figures, and statements before making any decision based on this content.
AInvest Fintech Inc. its affiliates, and partners accept no liability or responsibility for any direct or consequential losses arising from reliance on this content. All articles and analyses are subject to revision, update, or removal without prior notice to maintain accuracy and integrity in our publications.
Comments
No comments yet