HYRNUO (sevabertinib)

Sevabertinib pharmacokinetics were observed at steady state in patients with advanced NSCLC harboring activating HER2 or EGFR mutations at the approved recommended dosage and are presented as mean (CV%), unless otherwise specified. Sevabertinib maximum concentration (C max ) is 902 (45%) ng/mL and total systemic exposure (AUC) is 6,640 (50%) ng*h/mL. Sevabertinib C max and AUC increase in a dose-proportional manner across the dose range of 10 mg to 80 mg (0.25 to 2 times the approved recommended...

14.1 Locally Advanced or Metastatic Non-squamous NSCLC with HER2 TKD Activating Mutations The efficacy of HYRNUO was evaluated in SOHO-01 (NCT05099172), an open-label, single-arm, multicenter, multi-cohort clinical study. Eligible patients (Groups D and E) were required to have previously treated locally advanced or metastatic NSCLC with HER2 ( ERBB2 ) activating mutations and have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. HER2 ( ERBB2 ) activating mutations were determined in tumor tissue or plasma by local laboratories prior to enrollment. Patients with tr...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Diarrhea [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.3) ] Ocular Toxicity [see Warnings and Precautions (5.4) ] Pancreatic Enzyme Elevation [see Warnings and Precautions (5.5) ] Most common adverse reactions (>20%) : diarrhea, rash, paronychia, stomatiti...

None. None. ( 4 )

Diarrhea : At the first sign of diarrhea or increased bowel movement frequency, instruct patients to start an antidiarrheal treatment, and to increase their fluid and electrolyte intake. Interrupt, reduce the dose, or permanently discontinue HYRNUO based on severity. ( 5.1 ) Hepatotoxicity : Monitor liver function tests including ALT, AST, and total bilirubin at baseline prior to administration of HYRNUO, every 2 weeks during the first month, and then monthly thereafter as clinically indicated, ...

7 DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce HYRNUO dosage. ( 2.4 , 7.1 ). Moderate CYP3A Inhibitors: Monitor patients for increased HYRNUO-associated adverse reactions ( 2.3 , 7.1 ) Strong and Moderate CYP3A Inducers: Avoid concomitant use with strong or moderate CYP3A inducers. ( 7.1 ) Certain CYP3A ...