Zykadia

Ceritinib

• Brand(s): Zykadia
• Dosage Form/Strength: 150mg capsule

Initial Criteria:

For the treatment of anaplastic lymphoma kinase (“ALK”) – positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients meeting ALL the following criteria:

1. Patient is using ceritinib as monotherapy; AND

2. Ceritinib is being used as second line¹ therapy in patients who have experienced disease progression to crizotinib OR in patients who have experienced intolerance² to crizotinib.

Exclusion criteria:

• Ceritinib will not be funded if the patient has experienced disease progression while on an ALK inhibitor other than crizotinib.
• Ceritinib will not be funded beyond third line therapy².

¹Time-limited funding will be considered case-by-case in patients with ALK-positive NSCLC who have progressed on chemotherapy and crizotinib OR crizotinib and an immune checkpoint inhibitor commenced prior to the public funding of ceritinib.

²Include details of the intolerance including the grade of toxicity and reasons why crizotinib was not able to be used, particularly in situations where a toxicity was deemed to be grade 1 or 2.

Recommended dose: 450 mg daily (Product Monograph dose update December 2018)

Renewal Criteria:

Ongoing funding will be considered in patients who have not experienced disease progression or unacceptable toxicities to treatment with ceritinib.

Approval duration of initial and renewal requests: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests