China approves HERNEXEOS® as first targeted oral treatment option for HER2-mutant advanced NSCLC at initial diagnosis
· Financial Post
Ingelheim, Germany – Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has been conditionally approved as monotherapy by China’s National Medical Products Administration (NMPA) as an initial treatment for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations.1 The approval is based on data demonstrating a 75.7% objective response rate, with full approval contingent on confirmation of clinical benefit in an ongoing trial. It represents another major milestone following the Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s NMPA for first-line treatment.4 The therapy is also approved for patients in China who have received prior treatment.5 Read More
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