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Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal
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Fusion42 · 28 September 2026 · Fusion42 review
Merck and Daiichi Sankyo withdrew their FDA accelerated approval filing for the lung cancer drug ifinatamab deruxtecan after the FDA found the current data insufficient. This setback delays potential market entry and affects competitors like Amgen and GSK, while ongoing trials continue for other indications.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 26 Sep 2026 and 28 Sep 2026.
◆ ◆ The Wire takeaway
The FDA's refusal to approve this lung cancer drug shifts your timing to market and competitive positioning. You must explore alternate drug indications and prepare for a longer regulatory path.
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2 sources · first reported 26 Sep 2026 · latest 28 Sep 2026
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