FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo

GSK plc (GSK) shares declined 4.7% after the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile of its Blenrep combination therapy for relapsed or refractory multiple myeloma. This negative recommendation, delivered just a week before the FDA's final July 23 decision on GSK's biologics license application, strongly suggests a likely rejection of U.S. approval, especially given Blenrep monotherapy's prior withdrawal from the U.S. market in 2022. While the Blenrep combination has secured approvals in the UK and Japan, the ODAC's stance presents a significant regulatory setback for GSK's efforts to re-establish the drug in the U.S.

Analysis

GSK plc has encountered a significant regulatory obstacle in the United States for its multiple myeloma drug, Blenrep. The FDA's Oncologic Drugs Advisory Committee (ODAC) voted against the benefit/risk profile of the Blenrep combination therapy, triggering a 4.7% decline in GSK's shares. This negative recommendation substantially increases the likelihood of a formal rejection by the FDA, which is scheduled to make a final decision by July 23. The situation is compounded by historical context, as Blenrep monotherapy was previously withdrawn from the U.S. market in November 2022 following the failure of the DREAMM-3 confirmatory study. While the current biologics license application is supported by positive data from the DREAMM-7 and DREAMM-8 studies, which both met their primary endpoints of progression-free survival, the ODAC's opinion suggests these results were insufficient to outweigh perceived risks for the U.S. regulator. This setback in the world's largest pharmaceutical market contrasts with recent approvals for the combination therapy in the United Kingdom and Japan, highlighting a critical divergence in regulatory assessment and jeopardizing GSK's strategy to revive the drug.

Key Decisions for Investors

• Investors should brace for a high probability of a formal FDA rejection for GSK's Blenrep combo by the July 23 PDUFA date, which could exert further downward pressure on the stock.
• The core issue is the drug's benefit/risk profile in the eyes of the FDA, so current GSK shareholders should monitor the company's strategic response and any revised plans for its oncology pipeline post-decision.
• Given the negative sentiment surrounding GSK's regulatory hurdle, investors seeking exposure to the biotech sector might consider evaluating the alternative stocks mentioned, such as Akero Therapeutics (AKRO), which the report notes has surged 95.3% year-to-date on the back of positive developments.