Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved Hyrnuo (sevabertinib) for patients with HER2 (ERBB2) mutation-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC), opening a new first-line treatment option for a difficult-to-treat form of lung cancer.
Hyrnuo is the first targeted therapy approved in Japan for this indication that can be used regardless of the line of therapy, including as an initial treatment. Sevabertinib is an oral, reversible, small-molecule tyrosine kinase inhibitor (TKI).
“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,” said Koichi Goto, Chief of the Department of Thoracic Oncology at the National Cancer Center Hospital East in Japan.
The Japanese approval is based on results from the global Phase I/II SOHO-01 trial. Among 73 patients with unresectable advanced or recurrent HER2-mutant NSCLC who had not received systemic therapy after being diagnosed with advanced or recurrent disease, the objective response rate (ORR) was 75.3%.
The median duration of response was 12.2 months, while median progression-free survival (PFS) reached 13.5 months. The most frequently reported adverse events were diarrhea, rash and paronychia, while treatment-related adverse events led to discontinuation in 3% of patients.
“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,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.
“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 U.S. 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.”
The Japanese decision adds to a growing list of regulatory milestones for sevabertinib. In November 2025, the U.S. Food and Drug Administration granted Hyrnuo accelerated approval for previously treated patients with advanced HER2-mutant NSCLC.
Earlier this year, China’s National Medical Products Administration approved sevabertinib as a monotherapy for adults with unresectable, locally advanced or metastatic NSCLC carrying HER2 activating mutations who have received one prior systemic therapy.
