572 - As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X?
Jennifer Carroll last edited by
This case would best be addressed during an opinion submission as we’d need to evaluate the specifics for your case (e.g. the study and the TMA). For example, it’s important to consider whether there is any evidence in the TMA that Health Canada has evaluated the product’s safety in patients with the concomitant condition of interest. It is possible that Health Canada would require additional lab testing or monitoring in patients with the concomitant condition (this is particularly conceivable for a condition like cancer). Caution is particularly warranted when the subpopulation relates to a concomitant condition or concomitant product, however, other factors (sometimes specific to the particular therapeutic area) may also warrant a cautious approach.