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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

abine 1,250mg/m(squared), given by 30 minute intravenous infusion, on days 1 and 8 of each 21 day cycle.

The four week schedule used gemcitabine 1,000mg/m(squared), given by 30 minute intravenous infusion, on days 1, 8, and 15 of each 28 day cycle.

Cisplatin has been used at doses between 75-100mg/m(squared) once every 3 or 4 weeks.

Non-Small Cell Lung Cancer - Single-Agent Use

The recommended dose of gemcitabine is 1,000mg/m(squared), given by 30 minute intravenous infusion. This dose should be repeated once weekly for three weeks, followed by a one week rest period. This four week cycle is then repeated.

Pancreatic Cancer

The recommended dose of gemcitabine is 1,000mg/m(squared), given by 30 minute intravenous infusion. This dose should be repeated once weekly for up to 7 weeks, followed by a week of rest. Subsequent cycles consist of once weekly injections for 3 consecutive weeks out of every 4 weeks.

Bladder Cancer - Combination Use

The recommended dose for gemcitabine is 1,000mg/m(squared), given by 30 minute infusion. The dose should be given on days 1, 8, and 15 of each 28 day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70mg/m(squared) on day 1 following gemcitabine or day 2 of each 28 day cycle. This four week cycle is then repeated.

Breast Cancer - Combination Use

The recommended regime is paclitaxel (175mg/m(squared)) on day 1 over 3 hours as an IV infusion, followed by gemcitabine (1,250mg/m(squared)) as a 30- 60 minute infusion on days 1 and 8 of each 21 day cycle. Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation of the combination.

Gemcitabine can be administered on an outpatient basis.

Dosage reduction is based upon the amount of toxicity experienced by the patient. Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte, and granulocyte counts and, if necess
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SOURCE Eli Lilly and Company
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