EC grants Xeloda broad approval for mCRC

The European Commission has extended its approval of Xeloda (capecitabine), an oral anticancer agent made by Switzerland's Roche, in metastatic colorectal cancer indications. The decision means that the drug is cleared as a therapy for all stages of mCRC in combination with any type of chemotherapy regimen, with or without Avastin (bevacizumab).

Roche said that the decision is based on data from the Phase III NO16966 trial, which showed that the combined chemotherapy regimen XELOX (Xeloda plus oxaliplatin) was as effective as FOLFOX (5-fluorouracil/leucovorin plus oxaliplatin) in mCRC patients, in terms of progression-free survival. The study also demonstrated that the addition of Avastin to either regimen increased PFS. A second Phase III assessment, NO16967, showed that XELODA achieved comparable PFS to FOLFOX-4 in late-stage mCRC patients who had experienced disease progression.

Xeloda was cleared as a first-line therapy for mCRC in Europe and the USA in 2001 (Marketletters passim), and has since been approved for cancers of the breast, pancreas and stomach by regulatory authorities around the world.