Roche submits cancer drug application to FDA

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.