FDA Expands Sevabertinib Approval to First-Line HER2-Mutant Advanced Non-Small Cell ...

The FDA expanded accelerated approval for sevabertinib to include first-line treatment of adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain activating mutations, based on a trial showing a 75% objective response rate in previously untreated patients.

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