The US FDA has granted accelerated approval to sevabertinib as a first-line treatment option for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

 

The approval, which follows FDA Priority Review and Breakthrough Therapy Designation, makes sevabertinib—an oral, reversible small-molecule tyrosine kinase inhibitor (TKI)—a new targeted treatment option for patients with HER2-mutated NSCLC who have not previously received systemic therapy.

 

“The FDA’s accelerated approval of sevabertinib marks an important advance for treatment-naïve patients with HER2-mutated NSCLC who historically have a poor prognosis,” said SOHO-01 lead investigator, Xiuning Le, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. 

 

“This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.”

 

The FDA’s decision is based on objective response rate (ORR) and duration of response (DOR) data from 69 treatment-naïve patients enrolled in the ongoing Phase I/II SOHO-01 trial, which is evaluating sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC.

 

In the treatment-naïve cohort, sevabertinib produced an ORR of 75%, including complete responses in 6% of patients and partial responses in 70%. Among responders, 73% maintained their response for at least six months. The safety profile was consistent with previous findings.

 

The accelerated approval remains subject to confirmation of clinical benefit. Continued approval may depend on results from the ongoing Phase III SOHO-02 confirmatory trial, which is comparing sevabertinib with standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC.

 

“Today’s FDA approval of sevabertinib as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. 

 

“Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.”

 

The FDA action expands sevabertinib’s U.S. use following its accelerated approval in November 2025 for patients with previously treated advanced HER2-mutant NSCLC. That approval was also based on ORR and DOR data from the SOHO-01 trial, including patients who had not received prior HER2-targeted therapy and those who had previously received HER2-directed antibody-drug conjugates.

 

Sevabertinib has also gained regulatory momentum internationally. Earlier this year, China’s National Medical Products Administration (NMPA) approved the drug as monotherapy for adults with unresectable, locally advanced or metastatic NSCLC harboring HER2 activating mutations after one prior systemic therapy. The decision followed Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE).

 

The CDE has separately granted sevabertinib Breakthrough Therapy Designation for first-line treatment of advanced HER2-mutant NSCLC.

 

In Japan, sevabertinib has also been approved by the Ministry of Health, Labour, and Welfare as the first approved targeted therapy for this indication that can be used regardless of line of therapy, including in the first-line setting.