HYRNUO reached untreated HER2-mutant NSCLC before its Phase 3 answer. What does Bayer need to prove next?
The FDA has expanded HYRNUO into first-line advanced HER2-mutated non-small cell lung cancer after a 75% response rate in an early-phase cohort. The approval gives Bayer an important head start, but rival oral therapies and unfinished confirmatory trials mean the long-term treatment hierarchy remains unsettled.