FDA grants Hernexeos ‘Breakthrough’ status in NSCLC

German family-owned drug major Boehringer Ingelheim announced Hernexeos (zongertinib tablets) has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).

Analysts predict the drug could capture a substantial market share, with some estimating it could generate $1 billion in peak sales in the USA alone, potentially doubling with broader global and first-line use. whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. The drug targets a $36.5 billion market.