Sandoz Gefitinib

Gefitinib

• Brand(s): Iressa and generics (see formulary for funded OFIs)
• Dosage Form/Strength: 250 mg tablet

For the first line, monotherapy treatment of locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients who have activating mutations of epidermal growth factor receptor-tyrosine kinase (EGFR-TK). (i.e. Patients who are EGFR Positive)

The patient is to be assessed for disease status at least every two months and treatment will be discontinued if there is evidence of disease progression.

Dose Reimbursed: 250 mg orally once daily.

Duration of Approval: 6 months

Iressa will not be granted funding in the following circumstances:

• Patients with EGFR wild-type mutation (i.e., negative for mutation);
• Patients with EGFR unknown mutation;
• 2^nd or 3^rd line or maintenance NSCLC; OR
• Patients with unknown EGFR status who start their first chemotherapy while waiting for EGFR testing, then are found/confirmed to be EGFR positive, should continue with the current therapy and will not be eligible for gefitinib (Iressa) in this setting.

Patients who receive gefitinib (Iressa) first line are not eligible for erlotinib in the second- or third-line in the setting of maintenance therapy of NSCLC.

Requests for gefitinib for patients who have initiated another EGFR TKI therapy (i.e., Afatanib [Giotrif]) in the first line setting and who have not had disease progression will be considered on a case-by-case basis.

Renewal will be considered for patients until there is any evidence of disease progression, at which point, treatment with gefitinib (Iressa) must be discontinued. Patients must have their disease status assessed at least every two months.

Dose Reimbursed: 250 mg orally once daily.

Duration of Approval: 6 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests