Overview

• The FDA’s Oncologic Drugs Advisory Committee voted 5-3 against approving Blenrep for relapsed or refractory multiple myeloma.
• FDA staff reviewers raised concerns that the selected dosing caused high rates of keratopathy and visual acuity changes, suggesting that lower doses might reduce ocular toxicity.
• The FDA will deliver a final decision by July 23 and typically follows its advisory committee’s recommendations.
• GSK shares fell more than 6%, wiping over £3 billion off the company’s market value in London trading.
• GSK said it remains confident in Blenrep’s benefit-risk profile and will continue working with the FDA after securing MHRA approval in April.