Posted 3/25/2022 4:16 PM (GMT 0)
Another reason these treatment trials usually start with late stage patients is that if they were being tested at earlier stages they would have to prove that they are better than the already approved treatments in use. In other words they have to compete against other treatments and if not better, they don’t get approved. Thus, they are often tested in isolation generally after all else has failed to see if they help. Then, after approval, many docs start using them off-label at earlier stages. If that use is helpful, then the data can be used to get reimbursement and then becomes a more mainstream treatment.
Remember the recent approval of Orgovyx, an oral ADT that competes against leuprolides like Lupron and Eligard. The study had to prove that the drug offered advantages and was as good or better than the approved injectables already in use. The advantages shown were not in the aspect of cancer control, but rather in convenience of use, faster recovery after stopping use and a slim advantage in lower cardiovascular events during the trial. If the stated advantage was limited to cancer control, it is unlikely approval would have been granted. When the other aspects were put into the trial to differentiate Orgovyx from the others, then there were other reasons for approving a similar drug.