Erlotinib

Non-Small Cell Lung Cancer (NSCLC) Erlotinib is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations. Erlotinib is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.

Erlotinib is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Erlotinib is indicated when other treatment options are not considered suitable.

When prescribing Erlotinib, factors associated with prolonged survival should be taken into account. 1). Pancreatic cancer Erlotinib in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.

43 pms-ERLOTINIB Product Monograph Page 3 of 45 Pr pms-ERLOTINIB Erlotinib Hydrochloride Tablets 100 mg and 150 mg erlotinib PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-Medicinal Ingredients Oral Tablet / 100 mg and 150 mg Hydroxypropyl Cellulose, Hydroxypropyl Methyl Cellulose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Lauryl Sulphate, Sodium Starch Glycolate and Titanium Dioxide.

INDICATIONS AND CLINICAL USE pms-ERLOTINIB (erlotinib) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown (see CLINICAL TRIALS, Phase III Studies in NSCLC, Relation of Results to EGFR Protein Expression Status [as Determined by Immunohistochemistry]).

pms-ERLOTINIB is also indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations after 4 cycles of standard platinum-based first-line chemotherapy.

Non-Small Cell Lung Cancer (NSCLC) Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations. Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.

3 Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account. 1). Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.

1). No survival advantage could be shown for patients with locally advanced disease.