HYRNUO (sevabertinib) - (SOHO-01)

September 9, 2026: Bayer announced that the FDA granted accelerated approval to HYRNUO (sevabertinib) for first-line treatment of adults with locally advanced or metastatic non-squamous NSCLC with HER2/ERBB2 tyrosine kinase domain activating mutations detected by an FDA-authorized test.

The approval followed Priority Review and Breakthrough Therapy Designation and is based on Cohort F of the ongoing Phase I/II SOHO-01 trial in treatment-naïve patients (N=69). Reported efficacy was an objective response rate of 75% (95% CI: 64, 85), including 6% complete responses (n=4) and 70% partial responses (n=48). Among responders, 73% maintained response for at least 6 months and 38% for at least 12 months.

Continued approval may depend on confirmation of clinical benefit in the ongoing Phase III SOHO-02 trial (NCT06452277), which is comparing HYRNUO with standard of care in treatment-naïve advanced HER2-mutated NSCLC.

Bayer said the safety profile was consistent with prior findings. In SOHO-01, the most common adverse reactions over 20% were diarrhea, rash, stomatitis, paronychia, nausea, and decreased weight. The release also notes a prior accelerated approval in November 2025 for previously treated HER2-mutated locally advanced or metastatic NSCLC.