Tarceva

Erlotinib

• Brand(s): Tarceva and generics (see formulary for a funded list of generics)
• Dosage Form/Strength: 25 mg,100 mg, 150 mg tablet

For the treatment of clinically documented incurable progressive non-small cell lung cancer (NSCLC) where:

1. Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior chemotherapy (any regimen) in patients 70 years of age or older.

2. Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with clinically documented incurable progressive non-small cell lung cancer (NSCLC) despite prior chemotherapy including both docetaxel and a platinum-based treatment (i.e. cisplatin or carboplatin).

3. Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically documented incurable progressive non-small cell lung cancer (NSCLC) despite prior chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin) AND either pemetrexed or topotecan.

4. Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line platinum-based therapy, where no other chemotherapy will be given and erlotinib is used as the last treatment for the patient

Patients should be assessed for disease status at least every two months. Erlotinib should be discontinued if there is evidence of disease progression.

Note that erlotinib is not indicated and therefore, is not considered for reimbursement as 1^st line therapy in treatment of NSCLC.

Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and have not received treatment with either platinum-based combinations will be considered on a case-by-case basis.

Approved dosage: 150 mg/day

Duration of Approval: 6 Months

Renewal will be considered for patients who respond to therapy with no evidence of disease progression. Patients should be assessed for disease status at least every two months. Erlotinib should be discontinued if there is evidence of disease progression.

Duration of Approval: 6 Months

EAP Drug Request Form:

Standard Form for EAP Drug Requests