Quote:
The reason today was a downer is that George Sledge followed Dr. Piccart on the podium and presented the summary/editorial about what it all meant and then later on there was further discussion in a
postplenary"session. On both occasions, he and others generalized (perhaps overgeneralized) that this was likely going to be the early "end" of the FDA's new policy of approving new drugs based on pCR results in neoadjuvant trials(as occured with pertuzumab), without requiring the thousands of patients and tens of years required to produce a successful adjuvant trial.
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Lani - is there anywhere their presentation will be available to us? I am curious about the logic. I am a little resentful that the medical community feels the financial cost is too much to extend some lives. We're worth it! From my understanding the progress made by obtaining pCR in neoadjuvant treatments is having a great effect on DFS and OS. Is the data in Phase IV not showing this for Perjeta?
While I wholeheartedly agree we need to determine the subsets that can avoid chemotherapy - logic tells me we can work on determining other subgroups who need combined therapies to stay NED simultaneously.
I don't agree with the current system. It is broken. Any system that allows people to die to prove that something works is a terrible system. I'm offended that the FDA would go backwards after the progress with the quick approval of Perjeta for neoadjuvant treatment.