"hence, lengthening the time to progression confers a very meaningful QoL benefit."
laughable statement. QOL measures the symptomatic, physical, psychological wellbeing and social functioning, wherease TTP measures the radiological component. Gemzar did not improve QOL so its label does not allow such a claim. The oncologists on ODAC voted 9-2 against approval, period, if that does not represent opinion of oncology community, I don't what does! Maybe they should invite CTGTAC to vote on ODAC?
Gemzar is a great drug- but in the case of ovarian, FDA bent its rule, the blame was conviently shifted to Von Eschenbach.
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