Zongertinib: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Zongertinib appears in the FDA drug-label database. Marketed as HERNEXEOS.

Drug class

Kinase Inhibitor (FDA established pharmacologic class)

Mechanism of action

HER2/Neu/cerbB2 Antagonists; Breast Cancer Resistance Protein Inhibitors (as stated on the FDA label)

FDA-approved use

HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. ( 1 ) This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1 )

FDA label via openFDA