The Ministry of Health, Labour, and Welfare (MHLW) in Japan has granted approval for Hyrnuo (sevabertinib) for the treatment of patients with HER2 (ERBB2) mutation-positive unresectable advanced or recurrent Non-Small Cell Lung Cancer (NSCLC).

In Japan, Hyrnuo is the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment. Sevabertinib is an oral, reversible, small molecule, Tyrosine Kinase Inhibitor (TKI).

Dr Koichi Goto, PhD, Chief of the Department of Thoracic Oncology, National Cancer Center Hospital East, Japan, said, “HER2-mutant NSCLC remains an area of significant unmet medical need. Sevabertinib has demonstrated clinically meaningful efficacy together with a manageable safety profile and offers a promising new treatment option for these patients. The availability of sevabertinib in the first-line setting, without restriction by HER2 mutation subtype, marks an important step forward in expanding treatment choices for both patients and healthcare professionals. We look forward to its potential as a new treatment option for patients.”

The MHLW approval is supported by data from the global phase 1/2 SOHO-01 trial (NCT05099172). In patients with unresectable advanced or recurrent HER2-mutant NSCLC who had not received prior systemic therapy following diagnosis of advanced or recurrent disease, the primary endpoint of Objective Response Rate (ORR) was 75.3 percent (95 percent CI: 63.9–84.7; N=73).

Median Duration of Response (DOR) was 12.2 months (95 percent CI: 8.8–not estimable; N=73), and median Progression-Free Survival (PFS) was 13.5 months (95 percent CI: 10.0–not estimable; N=73). The study also demonstrated a manageable safety profile, with the most frequently observed adverse events being diarrhea, rash, and paronychia. Adverse events leading to treatment discontinuation occurred in 3 percent of patients.

Christine Roth, Executive Vice President (EVP), Global Product Strategy and Commercialisation and Member of the Pharmaceuticals Leadership Team, Bayer, said, “The approval of sevabertinib by Japan’s MHLW marks an important advancement for patients with advanced HER2-mutant NSCLC, a patient population that has historically faced limited treatment options. Supported by results from the ongoing SOHO?01 study, this latest approval advances our precision oncology strategy and builds on earlier approvals in both the US and China. We continue to work with clinicians and diagnostic partners to support timely HER2 testing and appropriate access in line with the approved indication, with the goal of improving outcomes for people living with this difficult?to?treat form of lung cancer.”

In November 2025, sevabertinib, under the brand name Hyrnuo, received US Food and Drug Administration (FDA) accelerated approval for patients with previously treated advanced HER2-mutant NSCLC.

Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. These approvals follow on from the FDA and the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation (BTD) for both first- and second-line use in patients with advanced HER2-mutant NSCLC, highlighting its potential to provide substantial improvement over existing therapies.

In May this year, the FDA granted sevabertinib Priority Review (PR) as a first-line treatment in this patient population recognising its potential to address a critical unmet need.