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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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.