Bayer Gains FDA Accelerated Approval for Sevabertinib in First-Line HER2-Mutant NSCLC

Bayer Healthcare Pharmaceuticals' sevabertinib (Hyrnuo) now carries an expanded accelerated approval, cleared for first-line use in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain activating mutations, a label extension that broadens the eligible patient population and sharpens the companion diagnostic requirement for manufacturers and QA teams supporting this programme.

The FDA granted the approval on September 9, 2026, building on sevabertinib's prior accelerated approval in the previously treated setting. Efficacy data from the SOHO-01 trial (NCT05099172), an open-label, single-arm, multicenter study, underpinned the submission. Among 69 treatment-naive patients, blinded independent central review using RECIST v1.1 recorded a confirmed objective response rate of 75% (95% CI: 64, 85); 73% of responders maintained response for six months or longer, and 38% for twelve months or longer. Tumour HER2 mutation status was determined in tissue or plasma by local laboratories prior to enrolment, a decentralised testing model that carries its own analytical validation obligations under 21 CFR Part 809.

The review was conducted under Project Orbis, the FDA Oncology Center of Excellence initiative that enables concurrent multi-jurisdictional submission and review. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) participated in this cycle; reviews at additional partner agencies remain ongoing. For regulatory affairs leads managing global dossiers, the Project Orbis framework means that CMC packages, process validation data, and sterility assurance documentation submitted to FDA will be scrutinised in parallel by MHRA, compressing the timeline for any post-submission queries across jurisdictions.

Prescribing information for Hyrnuo includes warnings for diarrhea, hepatotoxicity, interstitial lung disease/pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity. The recommended dose is 20 mg orally twice daily with food. Sevabertinib holds breakthrough therapy designation, orphan drug designation, and was granted priority review, a designation stack that signals the agency's expectation of confirmatory trial data to convert accelerated approval to full approval under 21 CFR Part 314 Subpart H.

The application also used the Assessment Aid, a voluntary applicant submission designed to streamline FDA's review workflow, a tool increasingly relevant to plant heads and regulatory leads preparing complex oncology submissions under compressed timelines.

The confirmatory trial data required to verify clinical benefit will set the next measurable checkpoint for Bayer's continued market authorisation of Hyrnuo in both the first-line and previously treated NSCLC indications.

Source: FDA Drugs Resources, Approved Drugs (What's New RSS Feed) via fda.gov, September 9, 2026.