Bayer announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib, an oral, targeted HER2 tyrosine kinase inhibitor (TKI), as a first-line treatment for patients with advanced HER2-mutant non-small cell lung cancer (NSCLC).
While previously authorized solely for patients who had received prior systemic therapy, this regulatory decision establishes sevabertinib as an upfront, chemotherapy-free therapeutic option for treatment-naïve individuals harboring activating HER2 alterations.
The accelerated approval is underpinned by compelling efficacy data from the Phase 1/2 SOHO-01 clinical trial, which demonstrated substantial and sustained antitumor activity.Patients achieved an overall response rate of 75%, driven by a 6% complete response rate and a 70% partial response rate.73% of responding patients maintained their clinical response for at least six months.The observed safety profile remained consistent with previously documented data for the molecule, with manageable adverse events.
Activating HER2 mutations define an aggressive, distinct molecular subset of lung cancer that has historically lacked targeted, oral frontline standard-of-care solutions. By selectively inhibiting the HER2 tyrosine kinase domain, sevabertinib halts critical oncogenic signaling pathways driving tumor proliferation, delivering clinically meaningful benefit directly at the start of therapy.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. Bayer is actively conducting the global Phase III SOHO-02 trial, which evaluates sevabertinib against current standard-of-care regimens to confirm definitive outcomes in the frontline setting.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
