Sanofi Genzyme said Tuesday it would launch its metastatic colorectal cancer injection Zaltrap in the Korean market early next month. The Ministry of Food and Drug Safety approved the drug in 2013 as the second-line treatment for metastatic colorectal cancer.
“Zaltrap is the first fruit of Sanofi’s open-innovation R&D strategy which has gained reimbursement after winning domestic approval four years ago,” said Sanofi Genzyme CEO Park Hee-kyung. “Making total solution care for metastatic rectal cancer possible will contribute to the long-term survival rate of Korean patients and resolve the unmet demand for existing treatments.”
The VELOUR clinical trial showed Zaltrap (ingredient: aflibercept) in combination with Folfiri proved statistical significance in all aspects of overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) compared to patients receiving a placebo-Folfiri combination, the company said. The trial involved 1,226 patients, including around 60 Korean patients with metastatic colorectal cancer.
It pitted a Zaltrap-Folfiri combination against a placebo-Folfiri combination, finding the Zaltrap arm had a median OS rate of 13.5 months versus 12.06 in the placebo group, cutting the risk of death by 18 percent. PFS was also longer in the combination arm at 6.9 months compared to 4.67 months in the placebo group. ORR was also significant, 19.8 percent versus 11.1 percent.
Colorectal cancer is a malignant tumor of the rectum and colon commonly referred to as rectal cancer and colon cancer. It was the fourth leading cause of cancer-related deaths in Korea in 2015, according to the company, with cancer reoccurring in around 20 to 50 percent of patients after radical resection.
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