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DrugXalkori® (crizotinib) [Pfizer]

January 2017

Therapeutic area - Oral Oncology

Initial approval criteria

  • Patient must be 18 years of age or older AND
  • Patient must have a diagnosis of metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive as detected by an FDA-approved test OR
  • Patient must have a diagnosis of metastatic NSCLC whose tumors are ROS 1-positive AND
  • At time of request, provide documentation of reproductive health counseling provided to female patients of reproductive potential and male patients with female partners of reproductive potential

Renewal approval criteria

  • Chart notes must be supplied at time of request showing patient has no disease progression AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
    • Severe vision loss (Grade 4 Ocular Disorder)
    • Bradycardia  with life-threatening consequences requiring urgent intervention
    • Interstitial lung disease/pneumonitis
    • QTc greater than 500ms or greater than or equal to 60ms change from baseline with Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
    • ALT or AST elevation greater than 3 times ULN with concurrent total bilirubin elevation greater than 1.5 ULN (in the absence of cholestasis or hemolysis)

Quantity limits

68 tablets per 34 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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