INDICATIONS AND USAGE（适应症）

RYBREVANT 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 the confirmatory trials.

DOSAGE（服用剂量）

Select patients for treatment with RYBREVANT based on the presence of EGFR exon 20 insertion mutations.

The recommended doses of RYBREVANT, based on baseline body weight as follows:

1050 mg for less than 80 kg

1400 mg for greater than or equal to 80 kg

Administer premedications before each RYBREVANT infusion as recommended. Administer diluted RYBREVANT intravenously according to the infusion rates, with the initial dose as a split infusion on Week 1 on Day 1 and Day 2. Administer RYBREVANT until disease progression or unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Infusion-Related Reactions

Interstitial Lung Disease/Pneumonitis

Dermatologic Adverse Reactions

Ocular Toxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/1466c070-9f97-4fa4-a955-6a6b59981fb8/spl-doc?hl=Amivantamab

Amivantamabinformation