03-12-2025 13:48 via pharmacypracticenews.com

FDA Grants Accelerated Approval to Hyrnuo for Nonsquamous NSCLC

Originally published by our sister publication Clinical Oncology NewsBy Clinical Oncology News StaffThe FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare), a kinase inhibitor, for adults with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD)-activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.FDA also approved the Oncomine Dx
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