FDA grants accelerated approval for Bayer lung cancer drug sevabertinib in first-line HER2-mutant NSCLC

• FDA granted accelerated approval for Bayer’s sevabertinib as first-line therapy in adults with advanced HER2-mutant non-squamous NSCLC.
• Clearance covers tumors with HER2/ERBB2 TKD activating mutations identified by an FDA-authorized test.
• Decision relied on SOHO-01 data in 69 treatment-naïve patients, showing a 75% objective response rate.
• Ongoing Phase III SOHO-02 trial could determine continued approval.

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