The MHLW approval covers all lines of therapy, including first-line use, in unresectable advanced or recurrent HER2-mutant NSCLC.
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved sevabertinib (Hyrnuo) for the treatment of patients with HER2 (ERBB2) mutation–positive unresectable advanced or recurrent non–small cell lung cancer (NSCLC).1 Sevabertinib is the first targeted therapy approved in Japan for this indication that may be used across all lines of therapy, including as first-line treatment.
The approval was supported by data from the global phase 1/2 SOHO-01 trial (NCT05099172). Among patients with unresectable advanced or recurrent HER2-mutant NSCLC who had not received prior systemic therapy following diagnosis of advanced or recurrent disease (n = 73), the objective response rate (ORR) was 75.3% (95% CI, 63.9%-84.7%). Median duration of response (DOR) was 12.2 months (95% CI, 8.8-not estimable [NE]), and median progression-free survival (PFS) was 13.5 months (95% CI, 10.0-NE).
“HER2-mutant NSCLC remains an area of significant unmet medical need,” Koichi Goto, PhD, chief of the Department of Thoracic Oncology at the National Cancer Center Hospital East in Japan, stated in a news release. “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.”
•MHLW approval makes sevabertinib the first targeted therapy in Japan for HER2-mutant NSCLC usable across all lines of therapy, including first-line.
•First-line efficacy in SOHO-01 included a 75.3% ORR and 13.5-month median PFS (n = 73).
•Most common treatment-related adverse events were diarrhea, rash, and paronychia; 3% of patients discontinued treatment because of adverse events.
SOHO-01 enrolled adult patients with locally advanced, recurrent or metastatic HER2-mutant NSCLC.2 Eligible patients received oral sevabertinib at 20 mg twice daily.
The primary end points were safety, determining the maximum tolerated and maximum administered doses, and ORR per RECIST 1.1 criteria by blinded independent central review. Secondary end points included DOR and PFS.
The SOHO-01 trial demonstrated a manageable safety profile in this population, with the most frequently observed adverse events being diarrhea, rash, and paronychia.¹ Adverse effects leading to treatment discontinuation occurred in 3% of patients.
The Japanese approval follows sevabertinib's accelerated approval by the
Earlier in 2026, sevabertinib was also approved by China's National Medical Products Administration as monotherapy for adult patients with unresectable, locally advanced, or metastatic NSCLC with HER2 activating mutations who had received one prior systemic therapy.¹ The agent previously received breakthrough therapy designation from the FDA and China's Center for Drug Evaluation for both first- and second-line use in advanced HER2-mutant NSCLC.
“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,” Christine Roth, executive vice president, Global Product Strategy and Commercialization and member of the Pharmaceuticals Leadership Team, at Bayer added in the news release.1 “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.”
