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erlotinib [Tarceva]

Phase 3
Roche Holding AG (RHHBY)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Drug Information

Target Indication

Non-Small Cell Lung Cancer

Clinical Trial

NCT01996332

Last updated: 1/8/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA9/19/2005

Tarceva

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.

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Mechanism of action & safety profile
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