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Bayer Gets FDA Priority Review For Hyrnuo In First-Line HER2-Mutated Lung Cancer

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Bayer AG (BYR.L) on Monday said the U.S. Food and Drug Administration has granted priority review for Hyrnuo as a first-line treatment for HER2-mutated non-small cell lung cancer.

Hyrnuo was approved in November 2025 for patients with non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations and who had previously received systemic therapy.

The application for first-line use is supported by clinical data from the ongoing Phase I/II SOHO-01 study in patients with locally advanced or metastatic HER2-mutated non-small cell lung cancer.

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