Sunvozertinib

China [CN]

Sunvozertinib (Zegfrovy®) – Simple Product Description

• Drug class: Oral, irreversible EGFR tyrosine kinase inhibitor (TKI)

• Indication: Non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations

• Mechanism: Selectively targets and blocks mutant EGFR, including exon20ins variants

• Approval status:

  • FDA (US): Accelerated approval (July 2025)

  • NMPA (China): Conditional approval (August 2023)

• Dosage: 200 mg once daily (oral tablet)

• Key efficacy: ~46–47% objective response rate (ORR) in pivotal trials; active against brain metastases

• Common side effects: Diarrhea, rash, stomatitis, nausea, fatigue