Summary
Can Xeloda replace 5-FU, it sure can! Though, I'm just as sure that it won't and data (in terms of efficacy) is not the reason for Roche's woes! The Spanish data has just added another brick in the wall of data supporting Roche's battle to get Xeloda to overtake 5-FU, though it’s already a pretty well developed wall! If anything the lukewarm reception that awaits the data further suggests that Roche has missed the boat on Xeloda!
Analysis
Since X-ACT and the approval of Xeloda, there has been a mountain of data (Phase 2 and Phase 3) to demonstrate equivalence if not superiority (in terms of efficacy and safety) of Xeloda vs. 5-FU (bolus and now infusional) for CRC (adjuvant and metastatic) as well as other tumor types where 5-FU is active such as breast & head and neck.
Xeloda's rather poor uptake has its roots going back years and its in the development and approval process, Roche never has answered the key question in the mind of many practicing Oncologists, what is the best way to use Xeloda?
Even today, ask three docs and you'll get four opinions as what is the best dose (mg/m2) and schedule for Xeloda and that is if you confine it to this side of the pond.
Couple this with reimbursement, compliance and toxicities, the Spanish data will do little to boost the lagging scripts for Xeloda!
Is Xeloda a failed drug, certainly not! It remains a standard armament in the toolbox of Oncology, it's just not the favorite one (comapred to 5-FU) and this data will do little to make it more attractive!
