Revised Prescribing Information for Oxaliplatin Includes 6-Year Survival Data

July 1, 2008

Sanofi-aventis US announced that the US Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include 6-year overall survival analysis from the MOSAIC trial in the oxaliplatin (Eloxatin) prescribing information (PI). The new PI also reports 5-year disease-free survival (DFS) data in stage III colon cancer patients treated following surgery to remove the primary tumor.

Sanofi-aventis US announced that the US Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include 6-year overall survival analysis from the MOSAIC trial in the oxaliplatin (Eloxatin) prescribing information (PI). The new PI also reports 5-year disease-free survival (DFS) data in stage III colon cancer patients treated following surgery to remove the primary tumor.

MOSAIC Data

The MOSAIC trial results showed that after a median follow-up of 6 years, stage III colon cancer patients treated with FOLFOX4 (oxaliplatin, leucovrin, fluorouracil) had a 20% reduction in the risk of dying compared to those treated with standard chemotherapy alone (hazard ratio [HR] = 0.80, 95% confidence interval [CI] = 0.65–0.97, P = .023). Stratified log-rank test was not adjusted for multiple comparisons. Also, stage III patients treated with the oxaliplatin-based regimen at 5 years were 22% less likely to relapse (HR = 0.78; 95% CI = 0.65–0.93; P = .005) after 77-month follow-up.

“The MOSAIC 6-year follow-up data demonstrate that as an adjuvant treatment for stage III colon cancer, the Eloxatin-based regimen significantly lowered the risk of death and recurrence,” said principal investigator Aimery de Gramont, md, Oncology, Hospital Saint Antoine, Paris.

In the MOSAIC trial, neutropenia (decrease in the number of white blood cells) was the most frequently reported side effect, affecting 78.9% of patients. Neutropenia was complicated by fever or infection in only 1.8% of cases. Peripheral sensory neuropathy (“tingling or numbness” in the fingers or toes) occurred in 92.1% of patients treated with FOLFOX4. Half (48.2%) of the episodes were grade 1, and 12% were severe (grades 3 and 4). Partial or total recovery was observed within 18 months following treatment in most patients experiencing grade 3 peripheral sensory neuropathy. Patients treated with FOLFOX4 also reported nausea (73.7%), diarrhea (56.3%) and vomiting (47.2%).

“This announcement is welcome news for patients who have a significantly higher chance of surviving stage III colon cancer when treated with the Eloxatin-based regimen following surgery,” noted Dr. de Gramont. “Inclusion of these survival results in the new US Eloxatin PI marks an important milestone in the treatment of colon cancer.”