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SOHO-02 Trial Will Confirm Sevabertinib's Frontline NSCLC Benefit
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Fusion42 · 24 September 2026 · Fusion42 review
The FDA granted accelerated approval to sevabertinib for frontline treatment of HER2 mutation-positive non-small cell lung cancer (NSCLC) based on promising early trial results. The ongoing phase 3 SOHO-02 trial will confirm its benefit by comparing sevabertinib to standard chemoimmunotherapy, potentially converting accelerated approval to full approval.
This Wire brief sits within Fusion42's coverage of Drug Discovery, and 8 sources have reported it between 9 Sep 2026 and 5 Oct 2026.
◆ ◆ The Wire takeaway
You can prepare for expanded market access as sevabertinib moves closer to full FDA approval, shifting frontline NSCLC treatment standards and creating new competitive dynamics against chemoimmunotherapy. Watch for the SOHO-02 trial readout to time product positioning or partnerships in HER2-mutant lung cancer.
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8 sources · first reported 9 Sep 2026 · latest 5 Oct 2026
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