26 February 2026 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA authorised test.

This application is part of the FDA Commissioner’s National Priority Review Voucher pilot program, which is designed to accelerate the review of products with the potential to address key national priorities.

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