U.S. FDA Approves HYRNUO® (sevabertinib) for Previously Treated Patients with HER2-Mutated Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
BAYER AG S/ADR (BAYRY)
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Source: Business Wire
Following Priority Review, the U.S. FDA granted HYRNUO® (sevabertinib) approval for the treatment of adult patients with locally advanced or metastatic non-squamous 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. WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved HYRNUO® (sevabertinib), an oral, reversible, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic non-squamous 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.1This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval fo
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