Xalkori

Crizotinib

• Brand(s): Xalkori
• Dosage Form/Strength: 200 mg, 250 mg capsule
• Updated December 4, 2020

Initial Criteria:

For the treatment of locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients who meet the following criteria:

1. Crizotinib is being used as the first-line oral treatment for a patient with ROS1-positive NSCLC
   OR
   Crizotinib is being used as the first-line oral treatment for a patient with anaplastic lymphoma kinase (ALK)-positive NSCLC
   OR
   Crizotinib is being used as second line oral treatment for a patient with anaplastic lymphoma kinase (ALK)-positive NSCLC

   Note: Patients with ALK-positive NSCL who have progressed on Crizotinib in first line will not be eligible for funding in second line.

2. Patient has good performance status.

3. Patient is using crizotinib as monotherapy.

Renewal Criteria:
Renewals will be considered until clinically meaningful disease progression or the patient has experienced unacceptable toxicity.

Exclusion Criteria:
Crizotinib will not be funded as combination therapy with another treatment for the treatment of ROS1-positive NSCLC or for ALK-positive NSCLC.

Dosing: 250 mg orally twice daily

Approval duration of Initials and Renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests