I am at a turning point in my journey. My first PSMA PET confirms that my adenocarcinoma has reactivated and is no longer responsive to Abiraterone/pred and Lupron. My oncologist feels I would be a good candidate for Lutetium 177 PSMA therapy however there is no supply in Colorado except for a clinical trial at the University.
Does anyone know when Novartis is expected to resolve the manufacturing and supply chain problem? I can't find anything on the internet about the current state of the problem with the facility in New Jersey.
Will do an update on my status when I digest where things are and can get the time to make a cogent summary.
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DenDoc
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My husband is scheduled for his first Pluvicto treatment on August 25 in Gilbert, AZ at Banner. He will be the first commercial patient to receive this at this facility. Sounds like quite a few here on HU are also starting this journey.
My doctor said he thought it would be available in 2 or 3 months. That was a while back. I'm in the same situation as you. I would try the switch to Dexamethasone, that bought me some time.
I'm doing Cabazitaxel, mainly because it's the only other treatment available for me other than LU-177. Hoping it holds off the cancer long enough to get the LU-177. Chemo is something you could consider. First-line Docetaxel if you haven't had chemo yet, and second-line Cabazitaxel if you have. Seems like it's working so far for me.
I have had Carbazitaxel and Etoposide for small cell portion of my PC. Small cell cancer seems to not have changed since the chemo 4+ years ago. Will start Docetaxel in mid-September while awaiting the LU-177 PSMA treatment to be available here. Thanks
I think a lot of people are trying to make it until they can get LU-177. I wasn't thrilled about starting chemo, but it has pretty much eliminated the intense pain I was having in my hip. And took less than one week on the first cycle. That helps a lot.
They have resolved their manufacturing issues and are supplying hospitals with Pluvicto now on a triage basis. They manufacture it in Italy for protocol use, NJ for trial use.
TA, Thanks so much for the information. I can always count on you to have the answers when I cannot find them on my own. You are a great resource for this list. Patience is not a virtue I was given so I am always anxious to get information and get it out there. Will share with my oncologist who is depending on the Nuclear Med people to keep him informed. Bob
TA - I understand that in Germany and Belgium doctors are currently offering Lu-177. Do you happen to know if they are not subject to the same manufacturing delays, or are they perhaps scheduling in anticipation? Thanks for any intel you may have.
If they use Pluvicto or Lutathera, they rely on the Italian manufacturer for supply. If they use a different ligand (e.g., I&T, J591) they have different suppliers.
DenDoc, where did you end up getting your first PSMA scan in Denver? I happened to see your post from about 6 months ago just now about the lack of availability in the Denver area then and asking what people were using it for. My husband and I are in the Denver area and he got 1st PSMA scan at UCLA in 2020 before it was approved. Now his MO wants to do a CT and bone scan and we are questioning that. CT and bone scan at diagnosis with PSA of 70 showed nothing. Axumin with rising PSA after salvage radiation at 1.7 showed nothing. PSMA scan at around PSA of 2.0 showed 5 spots in prostate bed. The original PSMA scan gave us a chance to discuss possible radiation as opposed to starting ADT. The scan helps us make our treatment decision. Now my husband is looking at PSA rising again so we are discussing next best treatment options. I always thought that it was good to get the 1st PSMA scan even though we had to pay out of pocket because then when it became available we could use the first one as a baseline and compare apples to apples when we needed to make a new treatment decision. Getting CT and bone scan makes no sense to me. We are having a consult on this tomorrow, so I'm sure I will find out more. The RO at Rocky Mountain Cancer Center who did the salvage was the doctor who helped us with getting the 1st scan I asked my contact there about the availability at Rocky Mountain, but have not heard back. Current MO is with UC Health. Good luck in finding what you need. Keep us posted.
I am a Kaiser Member. I got mine at Rock Creek but they are also doing them at Lone Tree. I talked to the tech. It uses the same equipment as the regular PET scan, they just inject you with a different radioactive tracer. My MO said there is a learning curve for radiologist in reading them but he showed me my scan in his office and it looks very obvious where the activity is. I would think by now Rocky Mountain would have access somewhere but they are a “for profit” and may not want to lose the income by sending you to a competitor.
I know that sounds harsh but I am a retired KP doc and know the profit incentive is very high in those large corporate practices. I am pretty sure that St. Joseph’s is also doing them.
Thanks DenDoc. My husband is at UC Health, Anschutz now. He was told by MO at UC Health that they are having trouble getting insurance to pay for PSMAs. I asked Rocky Mountain about the status of PSMAs there because I was curious if they were having any issues, but no response. Glad you were able to get yours taken care of and hopefully it provided good information to help direct future treatment.
My MO is also at Anschutz, and I’ve spoken directly with one of the knowledgeable RO’s there — and the story I’ve gotten is this:
— I received a Ga-68 scan at Anschutz in January w/o any insurance problems…however, I have Medicare. Perhaps that’s the difference?
— at least as of early July, I was told Gallium-based PSMA scans at Anschutz are currently for “research only”; not sure what that means, but it didn’t matter in my case since I was able to get a Ga68 done at RMCC in Boulder rather quickly.
— It was apparently available at other RMCC’s in Denver also, w/o much lead time. That was late June, early July.
— Since my RMCC Ga-68 scan showed nothing, I scheduled a Pylarify scan at Anschutz; this had only about 6 weeks lead time. Availability on that was supposed to get better about mid-July, as I was told at least.
Perhaps you can look into the Pylarify?
I also found I had to be perseverant to get RMCC’s attention. There are multiple phone #’s, sometimes you can only leave messages, and each one seems to specialize (Ga-68 only vs F18 only vs Boulder only vs … it was absurd). But, there are one or two phone #’s I can get to you if you wish, where I had better communication. Let me know if you’d like this.
Thank you lokibear. After having a telehealth visit with the MO I understand better why he wants bone and CT scan at this time. It's because he's already fighting with insurance companies over getting them approved and he wants to use CT and bone scan for baseline before my husband starts Zytiga. Got about 1 1/2 years out of Zoledex, but PSA is on the rise again. It still irks me because I think PSMA is more accurate, but I at least understand the reasoning. If something changes and he needs another scan down the road to compare, it's just easier to get those quicker. Also, it's not going to change course of treatment at this time, too late for additional spot radiation and too early for LU-177. Down the road this may change.
My husband had his first Pluvicto treatment yesterday at Mayo in Rochester, MN. The orders went in on July 7, and within 2 weeks we had his schedule for all 6 doses. The isotope is flown in daily, and they treat 9 patients a day. He was originally scheduled to receive it on August 16, but his batch did not pass quality control at Novartis. Nuclear Medicine had to pivot and reschedule all 9 patients, and he had his treatment on August 19 instead. Luckily we only live 5 hours away and could be flexible.
The staff here is phenomenal. Clearly passionate about the work they do, willing to give up a summer Saturday due to the revised schedule. Painstakingly answering every question, and giving us direct phone numbers so I can get an immediate response when needed. I am impressed.
Novartis has received FDA approval to begin supplying Pluvicto for US commercial use from the Novartis Radioligand Therapy (RLT) manufacturing facility in Millburn, New Jersey. This is an important step forward.
Production will begin in the coming weeks and gradually ramp up. The
site is expected to contribute meaningfully to supply in the third
quarter after the anticipated approval of additional lines. Capacity
should continue to increase through the second half of this year,
helping to ensure a stable, reliable supply to patients. The RLT
manufacturing facility in Ivrea, Italy, will continue to supply the US
market.😀👍
What this approval means for patients in the short term:
Novartis are actively working with physicians in treatment centers administering Pluvicto to coordinate the scheduling of patient treatments.
With a gradual increase in new supply, Novartis expects to reduce the current issues that have led to treatment cancellations.
Over time, patients who previously could not start on Pluvicto may be able to schedule a treatment with their healthcare providers.
What this means for Pluvicto supply in the long-term:
The approval of the Millburn facility is a first step. Novartis says it will do it's best to deliver orders consistently while we scale up its RLT production capacity.😀👍
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