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Tarceva (Erlotinib) - Summary



TARCEVA (erlotinib) is a Human Epidermal Growth Factor Receptor Type 1/Epidermal Growth Factor Receptor (HER1/EGFR) tyrosine kinase inhibitor.

TARCEVA (erlotinib) is indicated for the following:

Non-Small Cell Lung Cancer

TARCEVA monotherapy is 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.

Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.

Pancreatic Cancer

TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

See all Tarceva indications & dosage >>


Media Articles Related to Tarceva (Erlotinib)

Published Phase III data shows significant OS benefit of afatinib compared to erlotinib in patients with SCC of the lung
Source: Lung Cancer News From Medical News Today [2015.07.06]
Boehringer Ingelheim has announced The Lancet Oncology has published results from the LUX-Lung 8 trial (NCT01523587).

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Published Studies Related to Tarceva (Erlotinib)

Randomized trial of erlotinib plus whole-brain radiotherapy for NSCLC patients with multiple brain metastases. [2014]
and its direct effect on brain metastases and systemic activity... CONCLUSIONS: Our study showed no advantage in nPFS or OS for concurrent erlotinib

ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. [2013]
regimen with bevacizumab for advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: The addition of erlotinib to bevacizumab significantly improved PFS

An evaluation of the possible interaction of gastric acid suppressing medication and the EGFR tyrosine kinase inhibitor erlotinib. [2013]
participants... CONCLUSION: This retrospective analysis found that the co-administration of AS

A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). [2013]
agents in platinum-pretreated non-small-cell lung cancer (NSCLC)... CONCLUSIONS: The addition of sunitinib to erlotinib did not significantly improve

Symptom and quality of life benefit of afatinib in advanced non-small-cell lung cancer patients previously treated with erlotinib or gefitinib: results of a randomized phase IIb/III trial (LUX-Lung 1). [2013]
in a double-blind, randomized, phase IIb/III trial (LUX-Lung 1)... CONCLUSION: In the LUX-Lung 1 trial, the addition of afatinib to BSC

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Clinical Trials Related to Tarceva (Erlotinib)

Erlotinib (Tarceva) vs. Standard Chemotherapy (Paclitaxel and Carboplatin) in Patients With Advanced NSCLC and ECOG PS 2 [Active, not recruiting]
The purpose of this study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated NSCLC and an ECOG PS of 2. The study will also evaluate the safety of single-agent erlotnib in this patient population.

Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients [Active, not recruiting]
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

Safety Study of Radiotherapy and Concurrent Erlotinib (TarcevaŽ) for Brain Metastases From a Non-Small Cell Lung Cancer [Recruiting]
Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first site of disease failure in between 15-30% of patients with non-small cell lung cancer (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance the effect of cranial irradiation (radiosensitizers) may improve the the response rates. Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to studies investigating the combination of Erlotinib and cranial radiotherapy, the present study will be performed to evaluate the safety of combining both these treatments.

Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma [Recruiting]
The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.

OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer [Completed]
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U. S. Food and Drug Administration (FDA).

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Reports of Suspected Tarceva (Erlotinib) Side Effects

Death (648)Diarrhoea (137)Rash (126)Disease Progression (66)Neoplasm Malignant (66)Fatigue (58)Nausea (53)Incorrect Dose Administered (53)Decreased Appetite (52)Dyspnoea (52)more >>

Page last updated: 2015-07-06

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