Onco-Summaries: Daily Oncology Updates at a Glance

01/09/2025

Boehringer’s zongertinib received accelerated approval in China for HER2-mutant advanced NSCLC (Ref)

China’s National Medical Products Administration (NMPA) approved Boehringer Ingelheim’s zongertinib (HERNEXEOS; HER2-selective tyrosine kinase inhibitor) monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have activating HER2 mutations and who have received at least one line of prior systemic therapy.

• The accelerated approval has been granted based on data from the Phase Ib Beamion-LUNG 1 trial

• Professor Wu Yilong from Guangdong Provincial People's Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG): "The absence of a well-tolerated oral drug targeting HER2, has been a long-standing challenge in the treatment of non-small cell lung cancer. The approval of zongertinib will change this landscape, setting a new treatment benchmark for HER2-mutant advanced non-small cell lung cancer. This innovative drug provides a highly effective, targeted, oral treatment option for this patient population, which has an extremely poor prognosis and very limited treatment choices."