Breakthrough FDA Approval: Zegfrovy (Sunvozertinib) Targets Rare Lung Cancer


 Administration granted accelerated approval to Zegfrovy (sunvozertinib) for adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, following progression on platinum‑based chemotherapy.

 Clinical Trial Highlights

  • Overall response rate (ORR): 46% (95% CI, 35–57%) as per the phase 1/2 WU‑KONG1B study involving 85 patients.
  • Duration of response (DoR): Median 11.1 months (95% CI, 8.2–not reached).
  • Manageable safety profile: Includes gastrointestinal effects, dermatologic and ocular toxicity, pneumonitis risks.

 Companion Diagnostic Innovation

On July 7, 2025, FDA also approved the Oncomine™ Dx Express Test (Ion Torrent Genexus Dx) to rapidly detect EGFR exon 20 insertions, enabling timely precision oncology decisions.

 Global Context & Future Developments

Sunvozertinib had previously received conditional approval in China (WU‑KONG6 study, Lancet Respiratory Medicine 2024).[A global Phase III trial (WU‑KONG28) comparing it to platinum doublets is underway.

About 2% of NSCLC cases harbor the rare EGFR exon 20 insertion mutation.

 Why This Matters

This FDA approval marks a major advance in treating a form of lung cancer known for resistance to chemotherapy. Sunvozertinib becomes the first oral targeted therapy for this mutation type. Experts say such “precision” drugs are reshaping oncology.

 What Patients Should Know

  • Recommended dosage: 200 mg orally once daily with food, continued until disease progression or intolerable side effects.
  • Potential side effects: diarrhea, rash, increased liver enzymes, interstitial lung disease/pneumonitis, ocular issues and embryotoxicity.
  • Physicians should confirm EGFR exon 20 insertions via the Oncomine Dx Express Test before initiating therapy.

 Looking Ahead

Confirmatory Phase III trials may expand the use of sunvozertinib into first-line treatment and broaden regulatory approvals worldwide. Its entry into the U.S. marks a turning point for patients with this aggressive and hard-to-treat cancer subtype.

References

  1. FDA grants accelerated approval to sunvozertinib for metastatic NSCLC with EGFR exon 20 insertion (FDA press release, July 2 2025).1
  2. OncLive: Safety profile, adverse events details (Kristi Rosa, July 2025).6
  3. Targeted Oncology: Oncomine Dx Express Test approval (Jordyn Sava, July 7 2025).10
  4. WU-KONG6: Sunvozertinib in China, Lancet Respir Med 2024.3
  5. WU-KONG1B primary endpoint met, global pivotal study (June 2 2024).17
  6. EGFR exon 20 insertions account for ~2% of NSCLC (genetic biomarker study, June 2025).13
Location: USA

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