FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non ...

The FDA granted accelerated approval to sevabertinib for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 TKD activating mutations, expanding its indication to include those who have not received prior systemic therapy. This approval followed evaluation in a clinical trial showing a 75% objective response rate and was part of Project Orbis collaboration.

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