New EGFR Inhibitor Approved for Lung Cancer
The FDA has approved sunvozertinib for certain patients with EGFR-mutated non-small Cell lung cancer.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sunvozertinib (Zegfrovy) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed on or after chemotherapy and has insertion mutations in exon 20 of the epidermal growth factor receptor (EGFR) gene.
The FDA also approved the Oncomine Dx Express Test as a companion diagnostic to detect these EGFR mutations in a patient’s tumor in order to determine their eligibility for treatment with sunvozertinib.
Sunvozertinib is a targeted therapy that inhibits certain mutant forms of EGFR—including those with exon 20 insertions, EGFR-sensitizing mutations, and other mutations—that can drive hyperactive signaling in cells and stimulate cancer growth. Sunvozertinib is active against EGFR mutants that also harbor the T790M mutation, which is associated with acquired resistance to earlier-generation EGFR tyrosine kinase inhibitors.
This is the first FDA approval for sunvozertinib, which is the third therapeutic to receive FDA approval to treat lung cancers with EGFR exon 20 insertion mutations, following amivantamab (Rybrevant) and mobocertinib (Exkivity). (Mobocertinib was later withdrawn from the market.) The discovery and early clinical testing of sunvozertinib were first reported in the AACR journal Cancer Discovery.
The approval is based on results from the multinational, open-label phase I/II WU-KONG1B trial involving patients with locally advanced or metastatic NSCLC that was previously treated with platinum-based chemotherapy and that harbors EGFR exon 20 insertion mutations.
Among the evaluable patients who received the 200 mg daily dose of sunvozertinib, 46% (39/85) experienced responses, and in half of these patients, the responses lasted at least 11.1 months.
The recommended dose for sunvozertinib is 200 mg orally every day with food until disease progression or unacceptable toxicity.
NSCLC is the most common type of lung cancer, which itself is the third most commonly diagnosed non-skin cancer in the United States. EGFR mutations are observed in about 20% to 50% of NSCLC cases, with EGFR exon 20 insertions observed in about 2% of lung cancer patients. According to federal statistics, it was estimated that 226,650 individuals would be diagnosed with lung cancer and 124,730 would die of the disease in the United States in 2025.
The FDA rendered its decision on July 2, 2025. Accelerated approval means that continued approval may be contingent upon a confirmatory trial. Please check this FDA web page for information about any accelerated approvals in oncology that may have been subsequently withdrawn and are no longer FDA-approved. Check this resource for updated information on all therapeutics regulated by the FDA.