RE:Bladder Cancer Canada caseThe treatment is needed and the evidence is good that it is better than all current alternatives in terms of convenience for patients and their urologists, safety and tolerability, and efficacy..
According to the latest results, 39% of patients have reached their 450 day assessments and 33% of them are CR. This CR rate will undoubtedly improve as more and more of the remaining 61 patients recieve their final assessment.
As things stand right now it's hard to see why BTD and/or AA would not be granted. A substantial proportion of patients in the trial have recieved a durable complete response that is14% better than Keytruda and 9% better than Adstiladrin. Could Theralse be waiting for even higher numbers to remove all doubt before applying?
ScienceFirst wrote:
"So don't worry about the FDA breakthrough decision. These patients clearly need additional alternatives to BCG, chemo and surgery."