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@medchemexpress.bsky.socialSep 11, 2026, 9:00 AM

The #FDA has granted accelerated approval to #sevabertinib (#Hyrnuo) for adults with locally advanced/metastatic non-squamous NSCLC harboring activating HER2 (#ERBB2) tyrosine kinase domain mutations.

SOHO-01 trial: 75% objective response rate in patients who had not received prior systemic therapy

@pharmaphorum.bsky.socialSep 10, 2026, 11:29 AM

#Bayer has won #FDAapproval for #oralHER2inhibitor #Hyrnuo as a #firstlinetreatment for advanced HER2-mutant non-small cell lung cancer (#NSCLC), just a year after it was cleared as a second-line option.

pharmaphorum.com/news/bayer-m...

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