Regulatory Daily Summary: What Happened on November 5, 2026

China extends sevabertinib to untreated HER2-mutated lung cancer

China’s National Medical Products Administration approved Bayer’s sevabertinib for previously untreated adults with unresectable, locally advanced or metastatic non-small cell lung cancer with activating HER2 mutations.1 The approval drew on 73 previously untreated patients in the ongoing Phase 1/2 SOHO-01 study.1

In that cohort, 75% of patients had an objective response, meaning their tumors shrank. Six percent had a complete response and 70% had a partial response.1 Among responders, 73% maintained their response for at least six months.1 The early results do not establish whether sevabertinib improves progression-free or overall survival compared with standard care.1

The FDA granted the drug accelerated first-line approval in September 2026. Japan authorized it for first-line use in August.1 The ongoing Phase 3 SOHO-02 trial is comparing sevabertinib with standard therapy in previously untreated patients.1 China authorized Boehringer Ingelheim’s zongertinib for first-line use in May 2026. Response rates from the two drugs’ studies should not be compared directly because the patients and follow-up differ.1

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