- Histologically or cytologically proven diagnosis of a primary or metastatic malignancy
that is positive for a chromosomal translocation or activating mutation involving the
ALK or ROS1 gene or an activating genetic alteration involving the c MET gene, as
determined by local clinical testing that is appropriately validated in accordance
with applicable regulatory guidelines and/or practice standards (patients with tumors
harbouring other genetic alterations that may potentially benefit from treatment with
crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case by case basis subject
to approval by the sponsor).
- Inability to swallow crizotinib capsules, adult patients of whom must either have a
feeding tube in place or have completed clinical evaluation of dysphagia without any
reversible causes identified.
- At least 12 months of age (patients case basis and discussed with the sponsor).
- Currently receiving crizotinib, another ALK inhibitor, or an investigational product.
- Adult patients who have been previously treated with crizotinib.