Bayer’s sevabertinib wins domestic approval for HER2-mutant non-small cell lung cancer
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Bayer’s non-small cell lung cancer treatment sevabertinib has obtained domestic approval. The Ministry of Food and Drug Safety announced on the 20th that it had approved the imported rare drug Hernew Ojeong (sevabertinib).
Sevabertinib is an oral, mutant HER2-targeted, reversible tyrosine kinase inhibitor approved by the FDA in November 2025 for previously treated nSCLC tumors with HER2 mutations. The FDA has authorized the drug to be used in patients with locally advanced or metastatic non-polarized non-small cell lung cancer who have previously received systemic therapy.
Sevabertinib is a drug used in the presence of a tyrosine kinase domain activation mutation in HER2, a protein involved in cell growth regulation. The occurrence of mutations in HER2 TKD overactivates the sub-signal pathways involved in cell proliferation and survival, promoting the growth and proliferation of cancer cells. The drug shows anticancer effects by inhibiting the growth of mutant HER2-expressing cancer cells.
The approval was largely based on positive Ph. 1/2 clinical data, following its previous Breakthrough Therapy and Orphan Drug designations. The Ministry of Food and Drug Safety has designated the drug as Global Innovation Product Rapid Screening Support System (GIFT) No. 43 and has been conducting rapid screening.
The Ministry of Food and Drug Safety said it will continue to help expand patient treatment opportunities by promptly reviewing and approving treatments that have been sufficiently confirmed for safety and effectiveness based on regulatory science expertise.