The FDA on Friday granted accelerated approval to zongertinib (Hernexeos) for non-squamous non-small cell lung cancer (NSCLC) patients harboring HER2 tyrosine kinase domain (TKD) activating mutations.

Approval of the tyrosine kinase inhibitor stipulates use in adults with unresectable or metastatic disease who have received prior systemic therapy and was based on results from the open-label, phase Ia/Ib Beamion LUNG-1 study .

Among 71 patients who received prior platinum-based chemotherapy but had not been previously treated with a HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate (ADC), the objective response rate (ORR) was 75%, with 58% having a duration of response of 6 months or longer.

Among 34 patients previously treated with platinum-based chemotherapy and

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