EGFR, epidermal growth factor receptor; mNSCLC, metastatic non-small cell lung cancer. BRIEF SUMMARY OFPRESCRIBING INFORMATION EXKIVITY ™ (MOBOCERTINIB) WARNING: QTc PROLONGATION and TORSADES DE POINTES • EXKIVITY can cause life-threatening heart rate-corrected QT (QTc) prolongation,including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation [see Warnings and Precautions (5.1)]. • Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc [see Warnings and Precautions (5.1), Drug Interactions (7.1, 7.3)]. • Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation [see Dosage and Administration (2.3)]. 1 INDICATIONS AND USAGE EXKIVITY is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 2 DOSAGE AND ADMINISTRATION 2.1 Patient Selection Select patients with locally advanced or metastatic NSCLC for treatment with EXKIVITY based on the presence of EGFR exon 20 insertion mutations [see Clinical Studies (14)]. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of EXKIVITY is 160 mg orally once daily until disease progression or unacceptable toxicity. Take EXKIVITY with or without food [see Clinical Pharmacology 12.3], at the same time each day. Swallow EXKIVITY capsules whole. Do not open, chew or dissolve the contents of the capsules.If a dose is missed by more than 6 hours, skip the dose and take the next dose the following day at its regularly scheduled time.If a dose is vomited, do not take an additional dose. Take the next dose as prescribed the following day. Dosage Modifications for Adverse ReactionsEXKIVITY dose reduction levels for adverse reactions are summarized in Table 1. USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], EXKIVITY can cause fetal harm when administered to a pregnant woman. There are no available data on EXKIVITY use in pregnant women. Oral administration of mobocertinib to pregnant rats during the period of organogenesis resulted in embryolethality (embryo-fetal death) and maternal toxicity at plasma exposures approximately 1.7 ...