Lu 177

[Fight11]

Any idea when Lu 177 will be rolling out? Hopefully sooner than later!!!

[CAMPSOUPS]

I can't answer that but expect someone will.

But how are you and hubby doing ?

Kind of you to take time to wish us all a good Christmas as you did.

Is hubby pretty much on no treatment at the moment ?

Seems nothing has been working for you so I as well as others I'm sure are concerned.

[Fight11 in reply to CAMPSOUPS]

Chemo it’s not working!!! Nothing seems to be working. Bone and CT scan will be coming up. Not sure what we can do next!!!

[CAMPSOUPS in reply to Fight11]

You continue to be in my thoughts. I hope for the best.

[Tall_Allen]

It's in the hands of the FDA now. That can take a while.

[Fight11 in reply to Tall_Allen]

Thank you !!!

[mrscruffy]

My MO who is a director at my cancer center expects to see it available before July. But in the end who knows. Have you looked for trials in your area

[Javelin18]

I feel for the struggle you’re enduring. Docetaxel dropped my PSA to 1/3, but it doubled within a couple months.

The FDA did give Lu-PSMA expedite status , which is supposed lead to a faster review. I’m pinning my hopes on Lu-PSMA for now. Hopefully it will be approved soon, and be more widely available. After that, I’m probably headed into the trial arena.

I know you were disqualified for one trial, are there others that might be available?

[Hidden]

According to this article regarding FDA approval, the decision will be made in the first half of 2022.

targetedonc.com/view/fda-gr...

A decision on whether to approve 177Lu-PSMA-617 for this indication will be made by the FDA in the first half of 2022.

[Survivor1965]

I was under the impression that approval was a slam dunk. This makes it sound like it could be denied.

[Javelin18 in reply to Survivor1965]

I think it is a slam dunk. The FDA awarded breakthrough status for it shortly after it was submitted for approval.

I understand that they have to maintain their process to keep approvals objective, and there are many other drugs they are reviewing, but there should be some sort of triage to push breakthrough drugs with a large need to the front of the line.

[EdBar]

During my visit with Dr. Sartor back in November he was hopeful for FDA approval during the first half of 2022. Of course things work slowly at the FDA.

Ed

[joeguy]

I was hoping to get into the PSMA fore trial which is for castrate resistant metastatic guys that havent yet had chemo. Unfortunately, I was told last week that the trials are on hold because no one can get LU-177 drugs due to supply chain problems.

[NWLiving in reply to joeguy]

Oh no

[j-o-h-n]

Bureaucracy.....

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday 01/11/2022 6:57 PM EST

[Hidden]

I don't know. LU-177 seemed very promising when I first heard about it on this site. A brother here on this site chose that treatment option and didn't do well at all. It would be nice if they could somehow determine in advance whether it was safe for a particular patient to pursue.

[joeguy in reply to Hidden]

I have heard about 1/3 do great, 1/3 do so so, and 1/3 don’t have any response

[Hidden in reply to joeguy]

The guy I am thinking of had worse than 'no response'. It seemed to be toxic to him, especially his bone marrow.

[CAMPSOUPS in reply to Hidden]

I know. When I saw the 1/3,1/3,1/3 it didn't seem to fit. And its been more than one person here with marrow and re-population/mutation of C cells.

If I am in line for it down the road I sure wish I could fortify my marrow before treatment or best yet as you say know if it will be successful.

[joeguy in reply to Hidden]

Yes, I suppose included in the 1/3 that dont have a response are the ones that also have a bad response. Seems like I heard the most common side effect is dry mouth from damage to saliva glands, but have also heard of a few bone marrow problems .

[slpdvmmd]

Keep in mind there will be delays and interpretations by Insurance to include CMS (Medicare) after the FDA says it has a role. Insurance will decide what groups are approved for treatment. Since studies are done in late stage disease this is where insurance will probably approve based on history with other meds in general. This is a real problem since I think when you look beyond Vision and read case reports and small series with radioligand therapy for prostate cancer IMO the real impact will be in early oligometastatic disease and in particular in lymph node metastasis. Early use will still require a trip overseas.

[noirhole in reply to slpdvmmd]

Lets hope not. But as you all know the insurance company approval is more important than convincing you medical team to try something on the fringe outside of SOC. Which really sucks. I have suggested many ideas only to hear that "insurance will deny that".

[slpdvmmd in reply to noirhole]

It might in some instances still be cheaper to go overseas, another sad but true fact.