Roche Submits sNDA for Xelox in Colorectal Cancer

Roche has submitted a supplemental new drug application (sNDA) to the FDA for the use of Xelox with or without Avastin in the treatment of metastatic colorectal cancer.

The submission to the FDA is based on results from two large, international, Phase III studies that showed Xelox -- a combination of oral Xeloda (capecitabine) and oxaliplatin -- to be as effective in terms of progression-free survival (PFS) as the current standard treatment, Folfox-4 (intravenous bolus and infusional 5-fluorouracil plus oxaliplatin). Study NO16966 also showed that Xelox in combination with Avastin (bevacizumab) further improved PFS 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," Ed Chu, deputy director of the Yale Cancer Center, said.

Study NO16966 initially compared first-line Xelox versus Folfox-4. The protocol was later amended to investigate Xelox plus placebo versus Xelox plus Avastin versus Folfox-4 plus placebo versus Folfox-4 plus Avastin. The study met its primary endpoints in showing that Xelox is as effective in terms of PFS as Folfox-4, and that the addition of Avastin to chemotherapy significantly improved PFS compared with chemotherapy alone.

The NO16967 trial studied 627 patients who had previously received chemotherapy and whose disease had returned or continued to progress following treatment with irinotecan in combination with 5-fluorouracil/leucovorin. The trial compared Xelox with Folfox-4 as second-line treatment. The study showed that Xelox is as effective as Folfox-4 in terms of PFS.