Adults with locally advanced or metastatic nonsquamous NSCLC with HER2 TKD activating mutations who have received prior systemic therapy.
Weight-based dosing; consult prescribing information. Oral once daily.
Tablets: per prescribing information
None listed in the prescribing information.
Diarrhea (62%), Rash (38%), Nausea (32%), Stomatitis (28%), Paronychia (24%), Fatigue (22%), Dry Skin (20%), Decreased Appetite (18%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Strong CYP3A4 Inhibitors: Caution.
Strong CYP3A4 Inducers: May reduce efficacy.
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.
Sevabertinib inhibits HER2 with activating TKD mutations, blocking downstream PI3K/AKT and RAS/MAPK signaling.
Metabolized by CYP3A4. Full PK in prescribing information.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Hyrnuo has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Hyrnuo (sevabertinib) 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.
Sevabertinib inhibits HER2 with activating TKD mutations, blocking downstream PI3K/AKT and RAS/MAPK signaling.
Diarrhea (62%), Rash (38%), Nausea (32%), Stomatitis (28%), Paronychia (24%), Fatigue (22%), Dry Skin (20%), Decreased Appetite (18%) Diarrhea 62% Rash 38% Nausea 32% Stomatitis 28% Paronychia 24% Fatigue 22% Dry Skin 20% Decreased Appetite 18%