INDICATIONS AND USAGE（适应症）

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, 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

DOSAGE（服用剂量）

Select patients with locally advanced or metastatic NSCLC for treatment with EXKIVITY based on the presence of EGFR exon 20 insertion mutations.

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, 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.

ADVERSE REACTIONS（不良反应）

QTc Prolongation and Torsades de Pointes

Interstitial Lung Disease (ILD)/Pneumonitis

Cardiac Toxicity

Diarrhea

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f1a91500-a944-4cb8-b4a8-ae278bcf728d/spl-doc?hl=Mobocertinib

Mobocertinibinformation