LEVERKUSEN (dpa-AFX) - Bayer AG (BYR.L) announced Thursday that the U.S. Food and Drug Administration (FDA) has approved Hyrnuo for the treatment of adults with non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and who have received a prior systemic therapy.
The approval is granted under the accelerated approval pathway based on objective response rate (ORR) and duration of response (DoR). Continued approval may depend on verification of clinical benefit in a confirmatory trial.
This regulatory decision is supported by data from the ongoing Phase I/II SOHO-01 trial.
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