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XALKORI (crizotinib) Indications And Clinical Use

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Indications And Clinical Use

XALKORI (crizotinib) is indicated as monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

XALKORI is indicated as monotherapy for use in patients with ROS1-positive locally advanced (not amenable to curative therapy) or metastatic NSCLC.

Efficacy in patients with ROS1-positive NSCLC was based on objective response rate (ORR) and Duration of Response (DR) in a single arm study with a limited number of patients (N=53) including 7 patients who are treatment naïve.

Using a validated ALK or ROS1 assay, assessment for ALK-positive or ROS1-positive locally advanced or metastatic NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance can lead to unreliable test results (see CLINICAL TRIALS section).

There are no data available demonstrating improvement in overall survival with XALKORI.

Geriatrics (≥65 years of age):

Of the total ALK-positive NSCLC patients in clinical studies of XALKORI (n=1669), 16% were 65 years or older and 3.7% were 75 years or older. No overall differences in safety or efficacy was observed between these patients and patients <65 years. No starting dose adjustment is required for patients 65 years or older (see Special Populations). Of the 53 ROS1 positive NSCLC patients in single arm Study A8081001, 15 (28%) were 65 years or older.

Pediatrics (<18 years of age):

There is no indication for the use of XALKORI in the pediatric population. The effectiveness of XALKORI in pediatric patients with advanced relapsed/refractory solid tumors and anaplastic large-cell lymphoma (ALCL) has not been established (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).

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