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# Accelerated OK for Boehringer Lung Cancer Drug
- URL: https://www.fdaweb.com/accelerated-ok-for-boehringer-lung-cancer-drug/
- Published: 2025-08-08T12:00:00.000Z
- Updated: 2026-09-14T15:18:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159652

FDA has granted Boehringer Ingelheim accelerated approval for Hernexeos (zongertinib), a kinase inhibitor for treating adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. The approval applies to patients whose disease has progressed following prior systemic therapy and whose mutations are detected by an FDA-approved test. In conjunction with the approval, the agency cleared the Oncomine Dx Target Test, developed by Life Technologies Corporation, as a companion diagnostic to identify the HER2 TKD activating mutations in eligible NSCLC patients.

Approval was based on data from the Phase 1/2 Beamion LUNG-1 trial (NCT04886804), an open-label, multi-center study evaluating zongertinib in previously treated patients, according to an FDA [news release](http://FDA has granted Boehringer Ingelheim accelerated approval for Hernexeos %28zongertinib%29, a kinase inhibitor for treating adults with unresectable or metastatic non-squamous non-small cell lung cancer %28NSCLC%29 harboring HER2 %28ERBB2%29 tyrosine kinase domain %28TKD%29 activating mutations. The approval applies to patients whose disease has progressed following prior systemic therapy and whose mutations are detected by an FDA-approved test. In conjunction with the approval, the agency cleared the Oncomine Dx Target Test, developed by Life Technologies Corporation, as a companion diagnostic to identify the HER2 TKD activating mutations in eligible NSCLC patients.     Approval was based on data from the Phase 1/2 Beamion LUNG-1 trial %28NCT04886804%29, an open-label, multi-center study evaluating zongertinib in previously treated patients, according to an FDA news release. %28XXINSERT LINKXX%29 Efficacy was measured by objective response rate %28ORR%29 and duration of response %28XXX DELETE – NOT USED AGAIN XXX%29, assessed by blinded independent central review.     In one cohort of 71 patients who had received prior platinum-based chemotherapy but no HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate %28ADC%29, zongertinib achieved a 75% ORR, with 58% of patients maintaining a response for at least six months, the agency says. In a second cohort of 34 patients who had previously been treated with both platinum-based chemotherapy and a HER2-targeted ADC, the ORR was 44%, with 27% showing responses lasting at least six months, it says.). Efficacy was measured by objective response rate (ORR) and duration of response, assessed by blinded independent central review.

In one cohort of 71 patients who had received prior platinum-based chemotherapy but no HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate (ADC), zongertinib achieved a 75% ORR, with 58% of patients maintaining a response for at least six months, the agency says. In a second cohort of 34 patients who had previously been treated with both platinum-based chemotherapy and a HER2-targeted ADC, the ORR was 44%, with 27% showing responses lasting at least six months, it says.