Sandoz AFAtinib

Afatinib

• Brand(s): Giotrif
• Dosage Form/Strength: 20 mg, 30 mg, 40 mg tablet

Initial requests:

For the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who meet the following criteria:

1. Afatanib is being used as first line therapy; AND

2. Afatanib is being used as monotherapy; AND

3. Patient’s cancer is EGFR positive

Dose: 40 mg orally once daily

Exclusion Criteria:

• Patients with EGFR wild-type, negative, or unknown mutation.
• Afatinib will not be considered for funding in patients who have progressed on a prior EGFR TKI targeted therapy.
• Not funded for 2^nd or 3^rd line or maintenance NSCLC.

Notes:

1. Patients should be assessed for disease status at least every two months. Afatinib may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of afatinib.
2. Patients who receive afatinib 1^st line are NOT eligible for erlotinib in the 2^nd or 3^rd line or maintenance NSCLC setting.
3. Requests for afatinib for patients who have initiated another EGFR TKI therapy (i.e., Iressa [gefitinib]) in the first line setting and who have not had disease progression will be considered on a case-by-case basis.

Renewal requests will be considered based on the following:

Afatinib 40 mg once daily may be continued until evidence of disease progression or development of unacceptable toxicity at which point the drug should be discontinued. Patients should have their disease status assessed at least every two months.

EAP Drug Request Form:

Standard Form for EAP Drug Requests