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U.S. Department of Health and Human Services

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FDA approves gemcitabine (Gemzar, Eli Lilly and Company)

On July 14, 2006, FDA approved gemcitabine (Gemzar, Eli Lilly and Company) in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy.

The approval was based on a single multicenter, international, open-label, randomized trial enrolling 356 ovarian cancer patients whose disease had relapsed at least 6 months after first-line platinum-based therapy. Patients were randomized to receive either gemcitabine 1000 mg/m2 on days 1 and 8 of a 21 day cycle plus carboplatin (AUC 4) administered on day 1 of each cycle (GC) or to receive carboplatin (AUC 5) administered on day 1 of each 21 day cycle (C).

One hundred seventy-eight patients received GC and 178 patients received C. Patients were comparable for age, baseline ECOG performance status, platinum-free interval, and first-line therapy regimen.

GC treatment resulted in a significant improvement in progression-free survival (PFS). Median PFS was 8.6 months for GC-treated patients and 5.8 months for C-treated patients [log rank p=0.0038; hazard ratio 0.72 (95%, C.I. 0.57, 0.90)]. A significant improvement in the investigator-assessed overall response rate was demonstrated for the addition of gemcitabine to carboplatin (47% versus 31%, p=0.0016), but not in the independently reviewed response rate that excluded sonography or physical exam findings (46% versus 36%, p=0.11).

Approximately 75% of patients in each arm received post-study chemotherapy, including 13 of 120 patients on the C treatment arm for whom post-progression chemotherapy drugs were known and who received gemcitabine after progression. No significant difference in overall survival was observed. The median survival was 18.0 months for GC-treated patients compared to 17.3 months for those receiving single-agent carboplatin [p=0.8977, hazard ratio 0.98 (95% C.I. 0.78, 1.24)].

Hematologic toxicity was the most frequent adverse event. Grade 4 (CTC) neutropenia, anemia and thrombocytopenia occurred in 29%, 6% and 5%, respectively, of patients receiving GC compared to 1%, 2%, and 1% of those receiving single-agent carboplatin. Red blood cell and platelet transfusions were more common in GC-treated patients. Grade 3 neurosensory toxicity was observed in 1% receiving GC and 2% of C-treated patients.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available in Drugs@FDA

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178 by mail using the Form 3500 

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