FDA expands sevabertinib approval in NSCLC

SOHO-01 data showed a 75% confirmed objective response rate among 69 patients without previous systemic therapy.

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The FDA granted accelerated approval to sevabertinib for adult patients with advanced nonsquamous non-small cell lung cancer with HER2 mutations.
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Sevabertinib was previously approved for patients who had received prior systemic therapy for the same condition.
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Efficacy was evaluated in the SOHO-01 trial, showing a 75% objective response rate among patients without prior systemic therapy.
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The recommended dosage of sevabertinib is 20 mg orally twice daily until disease progression or unacceptable toxicity.
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The FDA's review was part of Project Orbis, collaborating with the UK's Medicines and Healthcare products Regulatory Agency.

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