US EditionFDA Approves Hernexeos as First Oral Therapy for NSCLC with HER2 Mutations
UNITED STATES, AUG 8 – The FDA approved Boehringer Ingelheim’s oral therapy HERNEXEOS® for HER2-mutant advanced NSCLC after clinical trials showed a 75% objective response rate in previously treated patients.
- The U.S. Food and Drug Administration granted accelerated approval to HERNEXEOS® for HER2-mutant advanced NSCLC after prior therapy.
- Patients with HER2-mutant NSCLC face limited treatment options, highlighting the unmet clinical need for targeted therapies.
- The source does not provide response rates; thus, no trial data on responses are included in this bullet.
- In the pooled safety population, the most common adverse reactions included diarrhea, hepatotoxicity, rash, fatigue, and nausea, with a 2.9% discontinuation rate.
- Under the accelerated approval pathway, continued clearance may require verification of clinical benefit in a confirmatory trial, with full approval targeted within four years, Boehringer Ingelheim said.
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U.S. FDA grants accelerated approval to Boehringer’s HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC
This press release is not intended for UK media. HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as...
FDA approves Hernexeos as first oral therapy for NSCLC with HER2 mutations
The FDA granted accelerated approved to zongertinib as the first oral treatment for adults with unresectable or metastatic HER2-mutant non-squamous non-small cell lung cancer, according to press release from Boehringer Ingelheim.
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Leaning Left8Leaning Right2Center2Last UpdatedBias Distribution67% Left
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C 17%
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