Bayer receives US FDA approval for lung cancer drug Hyrnuo

Bayer has received expanded FDA approval in the United States for its cancer medication Hyrnuo, which contains the active ingredient sevabertinib. The drug is now authorized as an initial treatment option for adults with locally advanced or metastatic HER2-mutated non-small cell lung cancer (NSCLC).

This accelerated approval is based on data from the ongoing Phase I/II SOHO-01 study involving 69 untreated patients. The study reported an objective response rate of 75 percent, with 6 percent of patients achieving complete remission and 70 percent achieving partial remission. The safety profile was reported to be consistent with previous findings.

A Phase III study, SOHO-02, is currently underway to compare sevabertinib against standard therapy in untreated patients to support permanent approval for this new indication. Hyrnuo has previously received approvals for different uses in China and Japan.