FDA Drug Approval Summary: Erlotinib (Tarceva®) Tablets

MH Cohen, JR Johnson, YF Chen, R Sridhara… - The …, 2005 - academic.oup.com
Abstract On November 18, 2004, erlotinib (Tarceva®; OSI Pharmaceuticals, Inc., Melville,
NY, http://www. osip. com, and Genentech, Inc., South San Francisco, CA, http://www. gene …

Approval summary for erlotinib for treatment of patients with locally advanced or metastatic non–small cell lung cancer after failure of at least one prior chemotherapy …

JR Johnson, M Cohen, R Sridhara, YF Chen… - Clinical Cancer …, 2005 - AACR
Abstract Purpose: To describe the Food and Drug Administration (FDA) review and approval
of erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) for treatment of patients with locally …

A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or 2nd line chemotherapy …

FA Shepherd, J Pereira, TE Ciuleanu… - Journal of Clinical …, 2004 - ascopubs.org
7022 Background: In phase II studies, erlotinib has shown single agent activity in a number
of tumor types, including NSCLC. NCIC CTG BR. 21 is a randomized, placebo-controlled …

Erlotinib: Small-molecule targeted therapy in the treatmentof non-small-cell lung cancer

J Smith - Clinical therapeutics, 2005 - Elsevier
BACKGROUND:: Erlotinib is an oral tyrosine kinase inhibitor, 1026 targeting the human
epidermal receptor type 1/epidermal growth factor receptor, recently approved by the US …

The role of erlotinib (Tarceva, OSI 774) in the treatment of non-small cell lung cancer

R Perez-Soler - Clinical cancer research, 2004 - AACR
Erlotinib (Tarceva) is a reversible and highly specific inhibitor of epidermal growth factor
receptor (EGFR) tyrosine kinase. Phase I studies established a fixed daily oral dose of 150 …

Erlotinib hydrochloride.

J Dowell, JD Minna, P Kirkpatrick - Nature Reviews Drug Discovery, 2005 - nature.com
Abstract Erlotinib hydrochloride (Tarceva; OSI Pharmaceuticals/Genentech/Roche), a
member of a class of targeted anticancer drugs that inhibit the activity of the epidermal …

A phase I/II study of weekly high‐dose erlotinib in previously treated patients with nonsmall cell lung cancer

DT Milton, CG Azzoli, RT Heelan… - … Journal of the …, 2006 - Wiley Online Library
BACKGROUND. Preclinical studies have suggested that erlotinib at high doses may inhibit
additional sites downstream of the epidermal growth factor receptor (EGFR), resulting in …

Phase II clinical trial data with the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib (OSI-774) in non–small-cell lung cancer

R Pérez-Soler - Clinical lung cancer, 2004 - Elsevier
Abstract Erlotinib (OSI-774; Tarceva™) is an orally available, highly specific epidermal
growth factor receptor (EGFR) tyrosine kinase inhibitor. The results of 3 phase II studies with …

Erlotinib in previously treated non–small-cell lung cancer

FA Shepherd, J Rodrigues Pereira… - New England journal …, 2005 - Mass Medical Soc
Background We conducted a randomized, placebo-controlled, double-blind trial to
determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival …

[HTML][HTML] Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase IV Tarceva Lung Cancer Survival Treatment study

M Reck, N van Zandwijk, C Gridelli, Z Baliko… - Journal of Thoracic …, 2010 - Elsevier
Introduction: Erlotinib is a small molecule inhibitor of epidermal growth factor receptor
tyrosine-kinase activity that has been shown to significantly increase survival for patients …