# Bayer Hyrnuo regulatory approvals for lung cancer

> Live situation record from CLSTR: https://clstr.news/situations/bayer-hyrnuo-regulatory-approvals-for-lung-cancer
> Updated: 2026-09-10T06:03:31.000Z. Sources: 4. Developments: 2.

Bayer has secured regulatory approvals for its lung cancer drug, Hyrnuo (sevabertinib), in major international markets. 

In August 2026, Japan’s Ministry of Health, Labour and Welfare approved the therapy for patients with HER2-mutated non-small cell lung cancer (NSCLC). This approval allows the drug to be used as a first-line therapy, supported by data from the Phase I/II SOHO-01 study which showed an objective response rate of 75.3 percent.

Following this, the U.S. FDA granted expanded accelerated approval for Hyrnuo as an initial treatment option for adults with locally advanced or metastatic HER2-mutated NSCLC. This decision also relies on SOHO-01 study data, noting a 75 percent objective response rate. A Phase III study, SOHO-02, is currently underway to compare sevabertinib against standard therapies to support permanent approval in the United States.

## Timeline

### 2026-09-10: Bayer receives US FDA approval for lung cancer drug Hyrnuo

Bayer's cancer drug Hyrnuo, containing sevabertinib, has received FDA approval for use as an initial treatment for adults with HER2-mutated non-small cell lung cancer in the US.

3 sources. https://clstr.news/cluster/bayer-receives-us-fda-approval-for-lung-cancer-drug-hyrnuo

### 2026-08-24: Bayer receives Japanese approval for lung cancer drug Hyrnuo

Bayer has received approval in Japan for its cancer drug Hyrnuo (sevabertinib) to treat HER2-mutated non-small cell lung cancer, marking a first-line therapy option for the indication in the country.

2 sources. https://clstr.news/cluster/bayer-receives-japanese-approval-for-lung-cancer-drug-hyrnuo

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Cite as: Bayer Hyrnuo regulatory approvals for lung cancer. CLSTR, https://clstr.news/situations/bayer-hyrnuo-regulatory-approvals-for-lung-cancer