GSK's Blenrep Combination Fails to Gain FDA Advisory Committee Backing
Why we think this is neutral
The RNS announcement provides an update on the FDA advisory committee's review of GSK's Blenrep combinations for relapsed/refractory multiple myeloma. While the news is not positive, as the committee voted against the overall benefit/risk profile, it does not contain any of the mandatory news types that would require a more detailed analysis. Therefore, a neutral sentiment score is appropriate.
Key Points
- FDA advisory committee voted against the benefit/risk profile of Blenrep combinations for relapsed/refractory multiple myeloma
- FDA will consider the committee's recommendation as it finalizes its review on Blenrep
- GSK remains confident in the benefit/risk profile of Blenrep and will continue to work with the FDA
Summary
GSK plc (LSE/NYSE: GSK) notes that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations. The FDA will consider the recommendation of the committee as it finalizes its review on Blenrep in advance of the 23 July 2025 PDUFA date. GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA.