GSK Shares Plunge as Blenrep Revival Disappoints Expectations

GSK (GlaxoSmithKline) encountered a significant decline in its stock value following a disappointing FDA approval for its blood cancer treatment, Blenrep. The approval was more limited than anticipated, affecting its market performance. GSK aimed to revive the drug, which had received accelerated approval in 2020, before it was withdrawn in 2022 after failing its confirmatory study.

FDA Approval and Market Expectations

On Friday, GSK’s stock plummeted over 5%, reaching $43.19. The FDA approved Blenrep for specific combinations aimed at treating multiple myeloma patients who had already undergone a minimum of three prior lines of therapy. GSK hoped to secure approval for Blenrep as a second-line treatment, meaning it would be accessible to patients who had progressed after only one prior medication.

Blenrep’s Clinical Challenges

GSK compared Blenrep directly with Johnson & Johnson’s Darzalex in a clinical trial known as DREAMM-7. This study indicated that the Blenrep regimen significantly improved overall survival and progression-free survival compared to its rival. Overall survival refers to the duration patients live before succumbing to any cause, while progression-free survival tracks the time until cancer worsens.

Despite these findings, an FDA advisory panel raised concerns regarding ocular side effects associated with Blenrep. Reports included corneal ulcers and severe reductions in visual acuity. Consequently, the advisory committee voted that the risks outweighed the available benefits.

Company Statements and Future Perspectives

Despite the setbacks, GSK’s Chief Scientific Officer, Tony Wood, described the FDA approval as a “significant milestone.” He emphasized the urgent need for innovative therapies for multiple myeloma, as relapses are common among patients. Wood pointed out that Blenrep is unique, as it can be administered in community healthcare settings, where about 70% of patients receive treatment.

• Stock Drop: GSK stock fell over 5% to $43.19.
• FDA Approval: Limited to patients with three prior therapies.
• Clinical Trial: Compared Blenrep with Darzalex in DREAMM-7 study.
• Side Effects: Notable ocular side effects reported.

Blenrep continues to be a critical development in the fight against multiple myeloma, fulfilling a significant patient need despite regulatory challenges. GSK remains committed to addressing this vital area of oncology.