Story perspectives

FDA Approves Bayer's Hyrnuo, Boosts HER2 Lung Cancer Battle

11/22/2025

Summary

Story summary

On November 19, 2025, the U.S. FDA approved Bayer's Hyrnuo for HER2-mutant NSCLC, which accounts for 80-85% of U.S. lung cancer cases.
Hyrnuo is an oral kinase inhibitor priced at $24,000 monthly.
In clinical studies, 71% of patients without prior HER2-targeting treatments experienced tumor reduction, and 38% with prior therapy saw similar results.
The approval heightens competition with Boehringer Ingelheim's Hernexeos (approved in August) and adds a diagnostic test.

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Story summary

On November 19, 2025, the U.S. FDA approved Bayer's Hyrnuo for HER2-mutant NSCLC, which accounts for 80-85% of U.S. lung cancer cases.
Hyrnuo is an oral kinase inhibitor priced at $24,000 monthly.
In clinical studies, 71% of patients without prior HER2-targeting treatments experienced tumor reduction, and 38% with prior therapy saw similar results.
The approval heightens competition with Boehringer Ingelheim's Hernexeos (approved in August) and adds a diagnostic test.