Boehringer Ingelheim's (BI) zongertinib received accelerated approval in the US as the first oral HER2 tyrosine kinase inhibitor (TKI) for pretreated HER2-mutant non-squamous non-small cell lung cancer (NSCLC), demonstrating 75% response rate in chemotherapy-experienced patients. The approval is based on Phase Ib Beamion LUNG-1 trial data showing 58% of responders maintained benefits for ≥6 months. Zongertinib previously gained breakthrough therapy designation (BTD) in the country and is under priority review in China through partner Sino Biopharmaceutical.

The kinase inhibitor showed 44% efficacy in patients who progressed on HER2 ADCs like Enhertu, offering a new option for this molecular subset. BI plans full approval upon completion of ongoing Phase III trials, while Sino Bio advances China's regulatory submission for the first oral HER2 TKI in the Chinese market.

According to PharmCube's NextBiopharm® database, zongertinib holds the sixth position in the HER2 inhibitor race in terms of development progress, with three competitors already on the global market. Click here to request a free trial for NextBiopharm®.