<![CDATA[Sevabertinib Earns Japanese Approval Across All Lines in HER2-Mutant NSCLC]]>

RegulatoryapprovedsevabertinibPositive

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Summary

Japan's MHLW approved sevabertinib for HER2-mutant advanced or recurrent NSCLC across all treatment lines based on phase 1/2 SOHO-01 trial data. This represents the first regulatory approval for the drug in Japan across all lines of therapy for this indication.

Clinical Trial Data

Phase

1/2

Outcome Details

Approved for HER2-mutant advanced or recurrent NSCLC across all lines of therapy

Importance:7/10

Sentiment:

0.80

sevabertinibHER2-mutantNSCLCJapan approvalMHLWSOHO-01

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Published by Cancer Network on August 25, 2026 3:00 PM

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