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Tarceva (erlotinib)

Region

🇪🇺 EU

Active substance

erlotinib

Company

Cheplapharm Registration GmbH

Status

Authorised

Therapeutic area

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

EU approval

Mon 19 Sep 2005

Application

EMEA/H/C/000618

ATC

L01EB02

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Erlotinib Accord Application withdrawn · Accord Healthcare S.L.U.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.