Basic Information
Tarceva
Regulatory Information
EMEA/H/C/000618
September 19, 2005
34
November 21, 2024
Company Information
Germany
Weiler Strasse 5e Stetten 79540 Loerrach
Cheplapharm Registration GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Non-small cell lung cancer (NSCLC)** Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer 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. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. **Pancreatic cancer** Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Overview Summary
Tarceva is a cancer medicine used in non‑small-cell lung cancer (NSCLC) that is advanced (the cancer has started to spread) or metastatic (it has already spread to other parts of the body). It is used for: - previously untreated patients whose cancer cells have certain changes (‘activating mutations’) in the gene for a protein called epidermal growth factor receptor (EGFR); - patients with EGFR activating mutations whose disease is stable after initial chemotherapy. Stable means that the cancer has neither improved nor worsened with chemotherapy (medicines to treat cancer); - patients with EGFR activating mutations in whom previous chemotherapy has not worked; - patients without EGFR activating mutations in whom previous chemotherapy has not worked and other treatments are unsuitable. Tarceva is also used in patients with metastatic pancreatic cancer, in combination with gemcitabine (another cancer medicine). The medicine contains the active substance erlotinib.