Pluvicto delayed

[Tall_Allen]

I've heard through the end of the month. It is a global issue. It affects all SOC use as well as clinical trials.

fiercepharma.com/manufactur...

Update: they say "within 6 weeks"

novartis.com/news/media-rel...

[Bartonneal]

I was just prescribed that on Wednesday. The PSMA scan was hot in the ribs and spine. Also multiple lymph nodes. I am at 13 yrs from diagnosis. What a dance. We wait.

[RJ-MN]

I was to receive Lu177 next Tuesday; that got suddenly dropped two days ago. This morning I had a consult w/Kwon, who was disgusted with Novartis. He is now juggling 100+ Mayo/RST patients who had been scheduled. Some of them have no SoC options left. Kwon had a conference call this noon to find out more, but I have a return consult in 6 weeks. Meanwhile, Olaparib ...

[Leader4077 in reply to RJ-MN]

I too was scheduled for Lu177 with Dr. Kwon at Mayo this month. Yesterday, got a call from both Mayo and the Seattle Cancer Care Alliance(SCCA)with the bad news. SCCA was to start Lu177 treatments that same day, May 6…..yikes!

Here are some options to consider:

Start “full” cycle chemo again. One qualifier for Lu-177 is you have had chemo before but PSA started to rise again. I finished 6 cycles of Docetaxel last May 12, 2021. Choline 11 scan at Mayo a month later saw positive result on 11 of my 12 bone spots. Also, had 7 consecutive PSA drops down to 2.98 from 20.

Started rising in early fall 2021 despite starting Zytiga then………..still rising…..need to do something.

Second option, start chemo for a “short term.” Because Lu-177 requires you to be off chemo for 4 weeks before starting treatment, stop treatment when you get Re-scheduled. Six weeks projected delay announced by Novartis could stretch………Lu177 is for guys who are in need NOW.

Mike

Seattle

[Shooter1]

Ok'ed for use and then none available. Just what we need. I am discussing this treatment with my RO to follow xofigo if all goes well. So far xofigo isn't doing a thing to hold PSA back. Up another 288% from last month.... Life Is Good, fast climbing PSA not so much...

[Tall_Allen in reply to Shooter1]

Will insurance cover Xofigo->Pluvicto? They didn't allow Xofigo pretreatment in the VISION trial.

[TJGuy in reply to Tall_Allen]

Is any private insurance covering Pluvicto at this time? BCBS for example?

[Tall_Allen in reply to TJGuy]

I don't know. There's usually a delay as private insurance gets with the program.

[KocoPr in reply to Shooter1]

Hoping for the best for you

[Yorkielover2 in reply to Shooter1]

Yes we have had two conversations with Oncologist about this. Husband taking break to heal after chemo. Our treatment center was just letting Oncologists know they would be offering this treatment in weeks. Cancer makes you be patient under extreme stress.

[KocoPr]

I suppose the phase 1 trial at MSK will be put on hold also, which really stinks as by the time it is available my PSA will be out of range. It does say temporary which since the money to be made from this therapy is enormous I doubt it will be halted for to long.

[Cooolone]

Am I missing something? Click the link but it's just a title, no article or any additional information. Paywall? Registration required?

[Tall_Allen in reply to Cooolone]

Link works for me - no registration required. Try again maybe.

[leebeth in reply to Cooolone]

Link works for me, but otherwise just google it and the Fierce Pharma article comes right up. I googled “pluvicto delayed”

[garyjp9]

Thank you, Allen

[Cooolone]

Is so weird, couldn't see article on page using both Opera and Chrome browsers. Used Brave browser and it worked and could read article.

Thanks all for your help.

And sorry news for those using this or under trial! Is crazy! I hope it's all worked out and made available quickly!

Best Regards

[Ramp7]

Yesterday I received a call from Dana Farber explaining the delay. Hopefully straightened out in short order.

[Grumpyswife]

My husband is in the same heartbreaking situation. He was scheduled to receive Pluvicto on Tuesday, April 17. They called a few days ago and pushed it to April 27. Then yesterday said it wouldn't be available until sometime in June due to manufacturing delays. They also mentioned he may have to redo the scan, not Pylarify.

Meanwhile, he is currently receiving no treatment for his prostate cancer and his PSA is rampant.

[Tall_Allen in reply to Grumpyswife]

Very frustrating! FDA only approved Ga-68-PSMA-11 as a qualifier to get Pluvicto. I get it that they have to stick to the VISION protocol, but it is a mistake, IMO.

I wonder if he qualifies for the following clinical trial of Th-227-PSMA. Nordquist is an investigator. They seemed to have reached their quota in Omaha, but they will be starting up in St.Louis. It's a Bayer drug (they also make Xofigo) so the Novartis problems may not be an issue.

prostatecancer.news/2018/10...

[TJGuy in reply to Tall_Allen]

Just asked MAYO this week if they are using PSMA Ga68 for scan. Said no using Pylarify. Knowing the FDA requirement for 68, I was confused. Still am.

[TJGuy]

So what is the cost for Pylarify and cost for Pluvicto, anyone know?