News on Pluvicto delayed production

[noahware]

As I was waiting to get my second Lu-177 dose yesterday, I asked one of the Dana Farber people involved with my trial what he knew about the Novartis delay in production. He said an FDA report had just been released, and I found the following with a quick search:

fiercepharma.com/pharma/nov...

Excerpts:

"One month on, Novartis’ surprise radiotherapy production halt could be nearing its end, the company said Wednesday. Meanwhile, an FDA write-up has shed more light on the manufacturing hitches that likely played a role in the temporary supply squeeze on Novartis’ cancer meds Lutathera and Pluvicto."

"Quality issues, record-keeping shortfalls and cleaning deficits are just a few of the problems the FDA flagged at Novartis’ Millburn, New Jersey, plant during an inspection last fall. It remains unclear whether the production halt is directly tied to the FDA’s November inspection..."

"A company spokesperson said over email Wednesday that the company is 'preparing to restart radioligand therapy production' at the two affected sites and currently expects patients to start receiving doses again in a phased manner starting early this month.

“ 'As radiopharmaceutical therapies are made to order for specific patients and require coordination of radioisotope components, there is a need to plan ahead in order to ensure on-time delivery,' the spokesperson continued. 'As a result, Novartis has contacted treatment sites to reopen the ordering process as it prepares to restart production, so that it can more quickly and efficiently supply doses to patients. We expect that initial production supply may be limited as the different sites and lines restart, but we will do everything possible to address the accumulation of patient demand from these past few weeks as quickly as we can,' the spokesperson added."

Novartis still sees “no indication of any risk to patients from doses previously produced at these sites."

[Hidden]

Interesting!

Single Points of Failure…..stink.

[Tall_Allen]

I talked to them. They are taking orders which they expect to fill beginning mid-June. Hospitals will prioritize patients.

[Ramp7]

I believe we are both in the same trial. Received my 4th infusion this Wednesday at Chestnut Hill, Dana Farber.

[noahware in reply to Ramp7]

Yes, I think so... I got my #2 infusion at C Hill the day after you!

[acuphealing]

So sorry to hear of the delay! My husband is in dire need, right now of LU177 and is willing to go to the Australia Phase 3 trial of LU 176- but I bet they are affected, too.. any word on that rial? Anyone here in it? If so- do you have the trial information that we could contact them ASAP?

[noahware in reply to acuphealing]

I have no info on that trial... perhaps do a stand-alone post, requesting info?

I do believe the delays may be global in nature, and my guess (supported by the comment quoted above) is that supply will be phased back in with priority going to men who are already in the middle of a clinical trial (like myself and Ramp7 above).

What that means as far as delays for men wanting to enter a trial could only be answered by those who are managing and facilitating that particular trial. I hope you can track down that info!

[CJ4J]

Thank you for the update!! Husband has been waiting on a call from Mayo to be scheduled. So frustrating for everyone. In April my husband got the ok to allow him to get the treatment a second time. This is the only treatment left that my husband can do. He was in the original Vision trial. Then he had to wait a month to get the PSMA scan only to learn of the halt. His PSA is doubling monthly. He has been approved by the tumor board at Mayo, now we anxiously wait and try to be patient knowing his cancer is increasing.

[noahware in reply to CJ4J]

Sorry to hear how the delay is impacting you... I imagine that there are many others, too, still in limbo. My guess is that the first priority will be men already in the midst of a cycle of infusions, within a trial. Hopefully they can ramp up production to get everybody else on board as quickly as possible. Best of luck to you!