FDA OKs NGS Test for Tumor Profiling and as CDx for Sunvozertinib in NSCLC

The FDA granted sunvozertinib accelerated approval in early July 2025 for the treatment of locally advanced or metastatic NSCLC in patients harboring EGFR exon 20 insertion mutations following progression on or after platinum-containing chemotherapy.

The FDA has approved the in vitro diagnostic (IVD) assay Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer for use as a companion diagnostic (CDx) for sunvozertinib (Zegfrovy) in patients with non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations as well as in solid tumor profiling, according to a news release from the developer, Thermo Fisher Scientific.¹

According to the news release, the IVD assay has been shown to deliver genomic data in as little as 24 hours when used on the Ion Torrent Genexus Dx Integrated Sequence, depending on the number of samples and type of run. Furthermore, this approval serves to bring next-generation sequencing (NGS) to decentralized clinical settings closer to patients, helping to advance the accessibility of precision oncology tools as well as facilitate more timely decision-making.

“NGS has been instrumental in advancing precision oncology, but these insights often [are not] available early enough to inform real-world care,” Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific, stated in the news release.¹ “With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment…. This approval signifies the next step in our journey bringing rapid, decentralized NGS CDx to drug development.”

To increase accessibility to laboratories that may be smaller with less NGS expertise, the Genexus Dx Integrated Sequencer was developed to automate the NGS workflow. Additionally, the developers engineered the sequencer to generate timely CDx and tumor profiling reports.

Furthermore, Biodesix, a collaborator in the validation of the Oncomine Dx Express Test, will be the first laboratory to launch testing services.

“The Biodesix team is excited at the prospect of using the newly FDA-approved Genexus Dx Integrated Sequencer for clinical testing using the Oncomine Dx Express Test and for supporting our biopharmaceutical client projects,” Gary Pestano, PhD, chief development officer at Biodesix, stated in the news release.¹ "Automation of the systems for nucleic acid purification, library preparation, sequencing, and report generation has the potential to significantly improve our NGS laboratory workflows by reducing hands-on time and by delivering rapid turnaround times—from sample receipt to results.”

The FDA granted sunvozertinib accelerated approval for the treatment of locally advanced or metastatic NSCLC in patients harboring EGFR exon 20 insertion mutations following progression on or after platinum-containing chemotherapy in early July 2025.² The agent was previously granted priority review as a treatment for this patient population in January 2025.³

Top-line data supporting the approval came from the phase 1/2 trial WU-KONG1 trial (NCT03974022), which assessed sunvozertinib at a dose of 200 mg orally once daily among 85 patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. The confirmed overall response rate (ORR) was 46% (95% CI, 35%-57%), and a median duration of response (DOR) of 11.1 months (95% CI, 8.2-not reached) was observed in this patient population.

Warnings and precautions from sunvozertinib’s prescribing information indicate that the most common toxicities reported in patients treated with the agent included interstitial lung disease or pneumonitis, adverse gastrointestinal reactions, adverse dermatologic reactions, ocular toxicity, and embryo-fetal toxicity. The primary end points of the trial included safety and tolerability in part A of the trial as well as ORR per blinded independent review committee assessment using RECIST v1.1 criteria, with secondary end points including DOR, disease control rate, and plasma concentration.⁴

References

1. Thermo Fisher’s NGS assay receives FDA approval as a companion diagnostic for ZEGFROVY and for tumor profiling. News release. Thermo Fisher Scientific. July 3, 2025. Accessed July 7, 2025. https://tinyurl.com/3m9z7sw4
2. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. FDA. July 2, 2025. Accessed July 7, 2025. https://tinyurl.com/4n4a75cb
3. U.S. FDA granted priority review to Dizal's sunvozertinib new drug application. News release. Dizal Pharmaceutical. January 7, 2025. Accessed July 7, 2025. https://tinyurl.com/59syffnb
4. Assessing an oral EGFR Inhibitor, sunvozertinib in patients who have advanced non-small cell lung cancer with EGFR or HER2 mutation (WU-KONG1). ClinicalTrials.gov. Updated February 28, 2025. Accessed July 7, 2025. https://tinyurl.com/bddrzrp3