The submission to the FDA is based on results from two large phase III studies which showed Xelox to be as effective, in terms of progression-free survival, as the current standard treatment, FOLFOX-4. The studies also showed that Xelox in combination with Avastin further improved progression-free survival over Xelox alone.
“By showing Xelox to be as effective as FOLFOX in both the first and second line settings, these studies not only demonstrate its promise as a new combination therapy for patients with advanced colorectal cancer, but also support a potential alternative to intravenous chemotherapy with oral Xeloda,” said Ed Chu, Professor of Medicine and Pharmacology, Deputy Director of the Yale Cancer Center.
Xelox is an abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.
Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer.