Thread by @SarahKarlin

About to watch @realrickpazdur on @statnews #ASCO21 recap.

Pazdur is one of thoe FDA voices that silences the room when he pipes up. When he speaks, you listen.

@realrickpazdur @statnews .@realrickpazdur: People want to put regulations that don’t exist on us. For exmaple, we have to demonstrate that drug is safe and effective not that it is better than what we approved yesterday.

@realrickpazdur @statnews .@realrickpazdur: People must undersatnd we have to move on from the traditional overall survival endpoint to meet patients needs. #ASCO21

FDA's Paul Kluetz said he sees his work as colloborative with industry not confrontational as he thinks some of the public precieves it. to be.

Though FDA's Harprett Singh then chimes in to note it does sometimes get tense. Agency and company are not always on the same page.

.@realrickpazdur I think these 3 (his colleagues on panel) have been too politically correct for him.

says FDA is often confrontational. Companies often want path of least resistance and FDA is there pushing back.

"There is this inherent tension that always exists."

@realrickpazdur .@realrickpazdur: what we really want companies to do is do randomized studies looking at different doses before they go into pivotal study. very difficult to retrofit afterwards. --- relates to $AMGN's recently approved KRAS drug for lung cancer.

said FDA will be less forgiving in less refractory settings.

as an aside @realrickpazdur seems to be trying to make conscious effort to not dominate and let his colleagues weigh in. nice to see a manager do this.

@realrickpazdur .@realrickpazdur re dose finding: One of the other things we are emphasizing is to start including diverse populations early to figure out are there differences here (elderly, ethnic, gender, differences)

I've heard this from FDA folks at other times during #ASCO21.

.@realrickpazdur Unforutnate situation I have been railing on during proliferation of pd1 drugs, despite my admonitions there is not less there is more & we have to start asking do we need all of these drugs that are competeting against each other instead of advancing the field

@realrickpazdur Pazdur seems like he wants head to head trials but doesn’t expect to get them.

then we had a conversation on endpoints and debate around whether some non-OS endpoints are really OK -- Pazdur seems very set on idea can't hold things to standards haven't held other drugs/ cancer areas -- but this seems like slipperly slope????

Paul Kluetz - defending FDA accelerated approval program and FDA's commitment to reviewing drugs granted AA ---- I think the data doesn't quite back that up though. Lots of drugs linger forever with no confirmed clinial benefit.

.@realrickpazdur notes June will be the 10 year anniversary of the Avastin public hearing around revoking its accelerated approval in breast cancer.... this my first FDA advisory committee meeting coverage experience.

@realrickpazdur .@realrickpazdur re PD1/L1 accelerated approvals seems to be saying that PD1s generally very similar and often differences has been trial designs in whether drug succeeded or failed in one indication or not.

A failed trial is not a failed drug, he says.

Pazdur says FDA would be failing patients if they pullled good drugs because of poorly designed studies.

and here comes the accelerated approval and $BIIB question.....

@adamfeuerstein says he heard @realrickpazdur was brought in by FDA to help with situation.

@adamfeuerstein @realrickpazdur .@realrickpazdur: emphasizes that if you believe amloiyd beta is apprpriate surrogate marker then you can approve....

But isn't issue many studies seem to indicate it is not a good marker???

@adamfeuerstein @realrickpazdur .@realrickpazdur expresses openness to discloses complete response letters.

Poeple put their lives on the line in these studies, we owe it to the patients to make those disclosures.

FDA's Paul Kluetz says advisory committees are often used so FDA can be more transparent with a troubled application.

.@realrickpazdur says he favors keeping safety and efficacy determinations away from cost effectiveness determinations like QALY. its hard enough to do safety/efficacy and then cost can change on dime.

@realrickpazdur .@realrickpazdur says when he came to FDA in 1999 he said he didn't plan to stay at FDA more than 3 years. indicates has no financial motivation to move to higher paying gig now and doens't seem like he plans to retire.

@realrickpazdur and that is a wrap folks. This was a jammed packed interview. I might get assigned a story per minute.