Adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy.
300 mg orally once daily with or without food.
Capsules: 100 mg, 300 mg
None listed in the prescribing information.
Diarrhea (58%), Rash (42%), Stomatitis (30%), Paronychia (28%), Nausea (26%), Decreased Appetite (22%), Dry Skin (20%), Fatigue (18%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
CYP3A4 Substrates: May increase exposure; use caution.
Acid-Reducing Agents: Avoid PPIs.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Sunvozertinib is a potent, selective TKI targeting EGFR exon 20 insertion mutations that covalently binds to C797 in the EGFR kinase domain.
Tmax: 2-4 hours. Protein binding: ~92%. Half-life: ~50 hours. Steady state ~15 days.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Zegfrovy has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Zegfrovy (sunvozertinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.
Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.
Sunvozertinib is a potent, selective TKI targeting EGFR exon 20 insertion mutations that covalently binds to C797 in the EGFR kinase domain.
Diarrhea (58%), Rash (42%), Stomatitis (30%), Paronychia (28%), Nausea (26%), Decreased Appetite (22%), Dry Skin (20%), Fatigue (18%) Diarrhea 58% Rash 42% Stomatitis 30% Paronychia 28% Nausea 26% Decreased Appetite 22% Dry Skin 20% Fatigue 18%