Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

Crizotinib is indicated in the U.S. for the treatment of patients with metastatic non-small
cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as
detected by an FDA-approved test. Commercially available dosage forms are 250 mg and 200 mg
capsules. This expanded access protocol (EAP) is designed to provide access to an alternative
oral formulation of crizotinib for those patients who are unable to swallow capsules.

Inclusion Criteria:

- 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 <12 months of age will be evaluated on a case by
case basis and discussed with the sponsor).

Exclusion Criteria:

- Currently receiving crizotinib, another ALK inhibitor, or an investigational product.

- Adult patients who have been previously treated with crizotinib.