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Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
Date:9/21/2007

ultiforme, pruritus.

Cardiovascular and cerebrovascular: Uncommon: Myocardial infarction, angina pectoris, cerebrovascular accident, arrhythmias, transient ischaemic attack. (Usually when given in combination with other cytotoxic agents and with pre-existing cardiovascular risk.) Common: Chest pain.

For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at http://www.emea.europa.eu/humandocs/PDFs/EPAR/alimta/H-564-PI-en.pdf

GEMZAR ABBREVIATED PRESCRIBING INFORMATION

Uses

GEMZAR is indicated for the treatment of adults with:

Non-Small Cell Lung Cancer (NSCLC)

Combination use: In combination with cisplatin as a first-line treatment of patients with locally advanced (inoperable Stage IIIA or IIIB) or metastatic (Stage IV) NSCLC.

Single-agent use: The palliative treatment of patients with locally advanced or metastatic NSCLC.

Pancreatic Cancer

The treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas, including those with 5-FU refractory pancreatic cancer.

Bladder Cancer

The treatment of advanced bladder cancer (muscle invasive Stage IV tumours with or without metastases) in combination with cisplatin therapy.

Breast Cancer

In combination with paclitaxel for patients with metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline, unless clinically contra- indicated.

Dosage and Administration

The drug is only administered intravenously and not more than once per week.

Non-Small Cell Lung Cancer - Combination Use

Gemcitabine in combination with cisplatin has been investigated using two dosing regimens (three week schedule or four week schedule).

The three week schedule used gemcit
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SOURCE Eli Lilly and Company
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