Sunvozertinib Application Scope

Adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, after progression on platinum-based chemotherapy.

Characteristics

Ingredients: Active ingredient: Sunvozertinib (EGFR exon 20 insertion-selective tyrosine kinase inhibitor)
Properties: Oral, small-molecule EGFR inhibitor targeting exon 20 insertion mutations
Packaging Specification: 150mg, 14 tablets (7 tablets × 2 blisters) per box
Storage:
- Store at room temperature, 20–25 °C (68–77 °F)
- Protect from moisture (as per Drugs@FDA general storage guidance)
Expiry Date: As stated on the bottle—typically 24 months from manufacture (refer to actual product labeling)
Executive Standard:
- Meets FDA-approved New Drug Application standards (NDA)
- In some countries aligns with pharmacopeial standards (e.g., USP)
Approval Number: FDA NDA issued on July 2, 2025 (Zegfrovy)
Date of Revision: Label updated July 2, 2025 upon accelerated approval
Manufacturer: Jiangsu Dizal Pharmaceutical Co., Ltd. (marketed in collaboration under Dizal)

Guidelines for the Use of Sunvozertinib

Dosage and Administration:
- Recommended dose: 200 mg orally once daily with food
- Continue until disease progression or unacceptable toxicity
Adverse Reactions:

Common and serious adverse effects include:
- Gastrointestinal: diarrhea, nausea
- Dermatologic: rash
- Ocular toxicity (eye-related)
- Interstitial lung disease / pneumonitis
- Embryo-fetal toxicity
Grade 3+ treatment-related events (at 300 mg dose):
- Diarrhea (≈17.1%), elevated creatinine phosphokinase (≈10.8%), anemia, rash, increased lipase, neutropenia, hypokalemia, decreased appetite, asthenia
Contraindications:
- Do not use during pregnancy or in women of childbearing potential without effective contraception (due to embryo-fetal risk)
- Hypersensitivity to sunvozertinib or formulation components
Precautions:
- Monitor for pneumonitis (ILD); interrupt or discontinue treatment if severe
- Watch for GI toxicities, dermatologic and ocular issues
- Avoid in pregnancy and breastfeeding
- Use with caution in patients with pre-existing lung or eye disease

Interactions

Drug Interactions:
No specific strong CYP inhibitors/inducers listed yet; potential interactions may exist via common metabolic pathways—refer to full prescribing info
No major interactions publicly highlighted at this time

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
Prescription drugs must be purchased from designated suppliers based on a doctor’s prescription.