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Cullinan Seeks Approval for EGFR Inhibitor in NSCLC
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Fusion42 · 3 October 2026 · Fusion42 review
Cullinan Therapeutics has submitted a New Drug Application to the US FDA seeking approval for zipalertinib, an EGFR inhibitor, combined with chemotherapy as a first-line treatment for advanced non-small cell lung cancer with EGFR exon 20 insertions.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You face a new US regulatory door opening for targeted lung cancer treatment. Early engagement with US oncology prescribers and payers will help position your biotech or pharma startup alongside this emerging clinical option.
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1 source · 2 Oct 2026
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