Sites for Lu PSMA Early Access Program

[Javelin18]

Disappointing news today.

Got my PSMA scan Friday, which showed intermediate to high PSMA expression. Got MRI yesterday to confirm no central nervous system lesions. Ready to sign the informed consent form, and start Lu PSMA treatment. However, found the wait for treatment in the early access program at UCLA is currently two months long. My PSA will double in that time, so I'd rather not wait.

I called the Novartis number listed in the clinical trials website, to see if they could provide a list of other sites participating in the early access program. There is no automated option to get that information, so I picked the only automated option that would let me speak to a live person. The agent didn't know what I was talking about, but escalated it. Hopefully someone will call me back.

Does anyone on the forum knows of a list of US sites that are participating in early access, or have a suggestion on how to find them? I will try the FDA compassionate use program next.

[TeleGuy]

There is a contact phone number and email address in the clinical trial description, did you try that number:

clinicaltrials.gov/ct2/show...

[Javelin18 in reply to TeleGuy]

The US toll free number listed there is the number I called, which had no information on the Novartis Managed Access Program.

The clinical trials site lists another number, which rings to Switzerland. I visited Switzerland in my youth, and they are a multilingual country. I didn't recognize the language on the automated attendant, but they may have an option to speak to someone in English.

I sent an email to the general address listed on clinical trials website

[Javelin18]

I looked at the FDA Expanded Access website. The phone number for information on investigational drugs is 301-796-3400. I'll call tomorrow between 8 and 4:30 ET, and see if they have information on treatment sites.

[6357axbz]

Really good post…

[Javelin18 in reply to 6357axbz]

Thank you. I hope I get some useful information for all of us.

[tango65]

Perhaps, these links could help:

clinicaltrials.gov/ct2/show...

clinicaltrials.gov/ct2/show...

clinicaltrials.gov/ct2/show...

[Javelin18 in reply to tango65]

Thanks for pointing out those trials.

The problem with statistical reasoning is that it makes it hard for me to choose without data. Hard to guess which trial to choose. I have an appointment with Dr Aparicio at MD Anderson December 6 to get some advice. Was hoping for the first Lu PSMA treatment before then.

I’ve also consulted with Dr Dorff at City of Hope. I should reach out to her again.

[tango65 in reply to Javelin18]

To my knowledge, Lu 177 PSMA is not approved by the FDA, the only way to get the treatment is entering a clinical trial.

Which clinical trial forLlu 177 PSMA is going on at UCLA? I did not find any listed in clinicaltrials.gov

[Javelin18 in reply to tango65]

This is part of the expanded access program sponsored by Novartis. clinicaltrials.gov/ct2/show...

It allows early access to the therapy for patients that meet the same entrance criteria as the VISION trial

[tango65 in reply to Javelin18]

Thanks, really appreciate it.

[Hidden]

A Novartis representative with all the info on authorized sites in the USA is Rebecca Haynes. Her phone number is 646-799-6488. Her email is [e-mail].

[Javelin18 in reply to Hidden]

Thank you, I’ll call this morning

[slpdvmmd]

I found Luke Nordstrom incredibly helpful when I was looking into this. Understand there may be financial constraints but I has an appointment for treatment at the University of Heidelberg one week after I uploaded my scans for their review. I sincerely wish you the best in pursuit of care.

[noirhole]

I was told that the FDA is scheduled to vote in late December. Duke is currently offering PMSA scans in preparation for approval.

[Javelin18 in reply to noirhole]

That sounds better than the usual answer,” it’s expedited, so approval in the first half of next year.”

[Javelin18]

Heard informally that there are 4 sites currently participating: UCLA, Mt Sinai, Tulane and University of Chicago. UCSF is in the process of setting up their program, and I heard that University of Nebraska is in process of setting up.

[Javelin18]

An update on my early access. I was accepted by Novartis for the early access program, and was scheduled for my first treatment January 13. Since my cancer is aggressive I didn’t want to wait until then to start. I began the process of getting to Germany for treatment.

I got a call from the program coordinator at UCLA late Wednesday telling me there had been a cancellation, and a slot was open on Friday. I got my first treatment. I’ve had some pain in the usual areas, but it seems to be subsiding.

[Ramp7]

That sounds like great news. I was recently accepted into a Trial at Dana Farber. One condition of acceptance was I needed to get 5 sessions of radiation to my spine due to metastasis. Hoping for the best for you in the New Year.

[Javelin18 in reply to Ramp7]

Yes it was great news. I had my second treatment on December 17, and most of pain has gone away. I’ll get another scan at the end of February.