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Zongertinib NDA Submitted in Japan

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Published: 20th Feb 2025

Nippon Boehringer Ingelheim  that it has submitted a new drug application in Japan for zongertinib for the treatment of HER2 positive unresectable advanced or relapsed non-small cell lung cancer

The compound, also known as BI 1810631, has received orphan drug designation from the Japanese health ministry. It is an irreversible HER2-selective tyrosine kinase inhibitor, which is currently also under regulatory review in the US and China.

Condition: NSCLC/HER 2
Type: drug