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GSK's shares dropped 6% after a US FDA panel rejected the company's Blenrep drug combination for advanced multiple myeloma, citing that the benefits did not outweigh the risks. The decision casts doubt over the drug's approval in the US, the world's largest pharmaceutical market, which could impact GSK's oncology ambitions and annual sales. Analysts estimate up to £1 billion in annual sales could be at risk.

GSK's shares dropped by more than 6% on Friday following a U.S. Food and Drug Administration (FDA) panel's vote against the company's Blenrep drug combination for advanced multiple myeloma. The decision casts doubt over the drug's approval in the U.S., potentially impacting GSK's oncology ambitions and annual sales.

The FDA's Oncologic Drugs Advisory Committee (ODAC) reviewed the treatment and concluded that the benefits of the proposed dosing regimen did not outweigh the risks. The primary concerns were related to severe ocular toxicity, including blurred vision, photophobia, and dry eye, which were reported in over 90% of patients in late-stage trials [3].

The FDA's decision is non-binding, but it typically follows the advice of its expert advisers. GSK's shares fell as much as 7% to 1,315 pence, making it the top percentage loser on London's FTSE 100 index, which was up 0.2% [4]. Analysts at Berenberg and JPMorgan have expressed skepticism about the drug's chances of approval in the U.S., given the FDA's usual adherence to its advisory panels' recommendations.

The U.S. market is a significant opportunity for GSK, with multiple myeloma being the third most common blood cancer globally, with over 180,000 new cases diagnosed each year [2]. The drug is already approved in several countries, including the UK, Japan, and Switzerland, based on results from the DREAMM-8 trial [2]. However, the FDA's concerns over the drug's safety profile and dosing regimen could delay or even prevent its approval in the U.S.

GSK has forecast peak annual sales for Blenrep of over £3 billion ($4 billion). The setback from the FDA advisory vote comes at a time when GSK is focusing on expanding its pipeline to offset declining sales from top drugs and vaccines [5]. The company's shares are down about 2% for the year, including Friday's losses [4].

References:
[1] https://www.statnews.com/2025/07/17/blenrep-advisory-committee-fda-gsk-multiple-myeloma/
[2] https://www.investing.com/news/stock-market-news/gsk-shares-fall-after-fda-panel-votes-against-blenrep-combinations-for-myeloma-4141202
[3] https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-blood-cancer-drug-fails-secure-us-fda-advisers-support-2025-07-17/
[4] https://www.tradingview.com/news/reuters.com,2025:newsml_L6N3TF08M:0-gsk-shares-fall-after-blood-cancer-drug-likely-headed-for-u-s-rejection/
[5] https://www.ainvest.com/news/gsk-blenrep-setback-cautionary-tale-high-risk-oncology-bets-2507/