Bayer’s Hyrnuo (sevabertinib) received accelerated FDA approval as a first‑line treatment for adults with locally advanced or metastatic, non‑squamous NSCLC harboring HER2 tyrosine kinase domain‑activating mutations. The decision was based on the SOHO‑01 trial showing a 75% ORR, with 73% of responders durable at six months and 38% at 12 months. A randomized confirmatory study (SOHO‑02) is ongoing. The approval highlights the need for molecular testing and places Hyrnuo in direct competition with Boehringer Ingelheim’s Hernexeos.
Bayer’s Hyrnuo (Sevabertinib) Wins Accelerated FDA Frontline Approval for HER2‑Mutant NSCLC
Hyrnuo is now indicated for frontline use in a specific type of HER2-mutant NSCLC. Credit: UA Creative Microstocks / Shutterstock.com.
Bayer has received accelerated approval from the U.S. Food and Drug Administration to expand Hyrnuo (sevabertinib) into the frontline setting for adults with locally advanced or metastatic, non-squamous non‑small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain‑activating mutations, as detected by an FDA‑approved test.
Study Data Supporting Approval
The approval was based on results from the open‑label, single‑arm SOHO‑01 study (NCT05099172). Hyrnuo produced an objective response rate (ORR) of 75%. Among responders, 73% maintained their response at six months and 38% remained responsive at 12 months, demonstrating encouraging initial activity and durability in this molecularly defined population.
Regulatory Pathway And Next Steps
This is an accelerated approval, meaning Bayer must confirm clinical benefit in a randomized post‑marketing trial. The ongoing SOHO‑02 study (NCT06452277) will compare Hyrnuo with standard‑of‑care therapies in untreated patients with advanced HER2‑mutant NSCLC.
Molecular Testing And Diagnostics
The approval underscores the growing importance of routine molecular testing in NSCLC to identify actionable HER2 mutations. Several tissue and liquid biopsy assays now have FDA authorization for HER2 detection, including Guardant Health’s Guardant360 CDx (currently involved in a patent dispute with TwinStrand) and Life Technologies’ Oncomine Dx Target Test.
Clinical Context And Competition
HER2 mutations are relatively uncommon—estimated at about 1.8%–5.6% of NSCLC cases (Lung Cancer, 2026)—but are associated with poorer outcomes, in part because of a higher incidence of brain metastases. Hyrnuo will enter a competitive frontline landscape that already includes Boehringer Ingelheim’s Hernexeos (zongertinib), which received an accelerated frontline approval in February 2026.
“An important milestone for patients who remain in critical need for additional treatment options,” said Christine Roth, Bayer’s EVP of Global Product Strategy and Commercialisation.
Thoracic oncologist Dr Balasz Halmos has noted it may be difficult to separate Hyrnuo and Hernexeos on efficacy and safety alone, while Dr Roy Herbst of Yale New Haven Hospital described Hyrnuo’s first‑line response rates as "extremely high" and suggested combinations with chemotherapy could be considered in the future, especially after positive data from trials such as FLAURA‑2.
What This Means For Patients
Hyrnuo’s accelerated approval gives clinicians another targeted option for patients with HER2‑mutant, non‑squamous NSCLC, reinforcing the shift toward precision oncology. Final positioning will depend on confirmatory trial results and real‑world comparisons with competing agents.
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