Under the new Commissioner’s National Priority Voucher (CNPV) pilot program, the US Food and Drug Administration (FDA) has granted accelerated approval to zongertinib for the treatment of unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain-activating mutations.1
The CNPV aims to shorten the FDA’s review process from the typical 10–12 months to only 1–2 months, while maintaining safety and efficacy standards.2 The final decision for this case was reached 44 days after the supplemental new drug application was filed on January 13, 2026.2 This latest accelerated approval, announced in February 2026, extends this treatment option to patients who have not yet received prior therapy.2
Zongertinib received prior accelerated approval from the FDA in August 2025 for adults with non-squamous NSCLC harboring HER2 mutations who had previously received systemic therapy.2 Additionally, the FDA granted a proactive CNPV to zongertinib for the treatment of patients with HER2-mutated NSCLC in November 2025.2
Results from the phase Ib Beamion LUNG-1 study, presented at the European Society of Medical Oncology (ESMO) 2025 Congress, showed that zongertinib achieved an objective response rate (ORR) of 76%.2 This represents a significant improvement from the current standard of care, where 30–45% of patients are typically expected to demonstrate this response, according to a recent FDA press release.2
Overall, the data indicate a manageable safety profile for treatment with zongertinib. The most common adverse events (AEs) associated with treatment were diarrhea, rash, hepatotoxicity, fatigue, nausea, musculoskeletal pain, and upper respiratory tract infections.2 Hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryofetal toxicity were the most serious AEs associated with treatment.2
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