what are your questions about the Pluvicto shortage?

[Darryl]

I am meeting with several people (via Zoom) from Novartis next Monday March 6. If you’re effected by the Pluvicto shortage, please reply with questions you want me to ask.

[TeleGuy]

What are the quality control problems cited as the cause of two different delays? Are they related to the production of the 177Lu or the PSMA ligand or the process of combining the two?

[TeleGuy]

What backup sources of 177Lu have you established in the United States?

[Djangler]

When will you be allowing new patients at Dana Farber Cancer Institute to start receiving Pluvicto?

[StePeteMN]

Does bringing on new patients depend on getting the new jersey plant online? I'm a patient at Mayo. Here's a background article. fiercepharma.com/manufactur...

[db1966]

can Novartis commit to providing medication for patients who have already started treatment. Starting treatment and then not being able to do your 2nd or 3rd is going to affect patients well being. Most of us are in the last chance saloon experiencing significant pain. These patients should be prioritised.

[Bethpage]

Another member of HU made a post regarding this survey on a FB group for spouses of PCa patients. She urged members of the FB group who are also members of HU to participate in the survey. As admin of that FB group, I am bumping her post as often as I'm able.

[Darryl Partner]

Excellent That will be helpful Here's a shortened form of the URL for you to use. bit.ly/3YiCakm

And, here's a shortened version of the poll's URL bit.ly/3JbyfRM

The poll is just to show Novartis the impact of their failure to deliver. The "request for questions" from patients and spouses, etc, will be the most helpful. I will post Novartis responses soon after our meeting on March 6.

I will mention the participation of the FB group during our meeting with Novartis.

[Concerned-wife in reply to Darryl]

thank you for doing this!

[ehoneycutt29 in reply to Darryl]

Thanks my friend for doing this, I am supposed to get my 3rd treatment on 3/24 at Vanderbilt. So far, I have experienced any delays.

[HopingForTheBest1 in reply to ehoneycutt29]

You have experienced delays.??? Or a typo?

[ehoneycutt29 in reply to HopingForTheBest1]

Typo, I have not experienced any delays. Knock on wood!

[Bethpage in reply to Darryl]

I have posted in 7 US FB groups and in 2 Australian FB groups.

[Darryl Partner in reply to Bethpage]

You are a very good advocate.

[Bethpage in reply to Darryl]

There are a lot of spouses and partners with some big hopes pinned to Pluvicto. Many of them have already started. Some are waiting, worried to death. Anything I can do, I will.

[TeeJae in reply to Darryl]

My husband is getting Chemo and is finishing up some radiation tomorrow. The last time he got his chemo, his PSA had gone up a little. He's been on the wait list for Pluvicto since Aug at Emory in Atl. With his tumors growing and the cancer getting more aggressive, we went to Athens, Ga and signed up in Feb. He was scheduled for March 20th and that was moved to April and now we're seeing it's on hold indefinitely. My husband's chemo may not be working properly and if he doesn't get started on the Pluvicto then he's pretty much out of options!

[Loudlibrarian]

We just had a call from our MO at Duke that my husband should start Jevtana since they don’t expect him to get his first dose until July. That’s a pie in the sky estimate. They are scrambling for patients that are already on the treatment cycle. It’s a big deal for patients running out of options. Should we be making a loud fuss? Should we be calling the FDA? Squeaky wheels and all that.

[Seebs9]

It seems strange that all of a sudden a person at each manufacturing site opens the cupboard and discovers there is no product to ship.

I seem to remember a similar shutdown this time last year.

This last Thursday my VA Palo Alto Oncologist talked to me about my very recent PYL/PSMA scan and to schedule my first Pluvicto treatment. Calls back a half hour later to say there will be a 2 month wait hinting that it could be July.

Please ask them for a realistic date for shipments to resume and where patients waiting for their first dose as well as patients that have already started treatment to get product.

I will probably lose my left kidney over this.

[Hidden]

Thanks Darryl - Could you please give us an update after you have your zoom call as far as you have learned?

Thanks,

Tom

[Darryl Partner in reply to Hidden]

yes

[Hidden in reply to Darryl]

Thanks - I am at Mayo Phoenix and was told 2 days before first injection that none was available - appreciate your help.

[KocoPr]

Thank you Darryl for your vigilance

[MiaAmia]

Is there a manufacturing source in Canada? Is there any benefit to publicity or lobbying to overcome these delays? If yes to the second question, to whom do we direct our concerns?

[Darryl Partner in reply to MiaAmia]

I will let everyone know what I learn next week

[Gmailer]

Any idea if there is a shortage in India. When I was there last month he told me they were doing Lu177 at Medanta Hospital in Gurugram, India(Delhi). I had mentioned to him I was going to go have it at Fortis where a couple of guys here went to. They had decent results. That's when he told me they have it at Medanta. Hadn't been there before COVID. He then mentioned I can do it there, but I wasn't a candidate yet because my PSA is still too low at .08. It is finally starting to go up. It won't be too long before it hits .50. He did say they would do it right away since it works better when someone doesn't have it as bad. It is around $20,000.00 for three treatments. Of cheap, but better to get it right away than waiting on it to put more tumors in me. I was dx'd in 8/2014 with PSA of 212 with it everywhere. Didn't know it was in my bones until I did the first PSMA PET scan in 3/17 and it was all over in my bones then. Thankfully they had the G68 back then. I was not very happy about having it in my bones back then. That's when APAC Biotech used my tumor to make the antigen to get it out of the bones back in the summer of 2017. Pretty amazing really. I have been on the ADT injections for two times for 2 1/2 years total. Was on Zytiga even though it quit working after just a bit of time until they got it out of my bones. It gave me over 4 good years with it again. We'll see what they say. I will try the doctor at Medanta before then if I can get ahold of him via WhatsApp. Better than Lupron etc that is injected into us. I hate it miserably.

Best,

Chris

[GP24]

Here is a report about the Pluvicto shortage:

fiercepharma.com/manufactur...

New patient starts paused

Novartis temporarily stopped accepting new patients as “the difficult but necessary step,” the spokesperson confirmed, until it has “more clarity on the FDA’s approval” of a manufacturing site in Millburn, New Jersey.

[strummer]

What is your estimate to allow new patients to be added to wait list?

[MaxWife]

currently being wait-listed for Pluvicto as docetaxal losing effectiveness. Hoping carbazitaxal works long enough to get through this shortage…

Thought you could share this link that includes latest update AND a sample form letter to the FDA. I believe it is for professionals, but could certainly be modified.

snmmi.org/NewsPublications/...

Why is this not in the news? FDA needs to prioritize this as it did for many “unproven” Covid-related issues.

Thank you for all you do