CU6 (ASX) Ann: First patient imaged in Phase III AMPLIFY trial

Originally posted by ttppxx: ↑

In the videos that I have watched - the speakers that were indifferent were speaking about their preference between Pylarify or Illuccix. The question asked related to some claims that images are clearer with Pylarify, yet research seems to suggest a marginal difference.

Having said that, in the videos that I have watched, the people expressing this were Oncologists and Urologists! There were no Radiologists! I'm not sure why.

Anyhow: on that subject of Pylarify and Illuccix performances.

POSLUMA APPROVAL - 2023!
Here is what the FDA document has on how the then existing tracers performed (per Posluma approval documentation - 2023)

In the presence of both Pylarify and Illuccix , the FDA reviewers made the following statements;

But then, Posluma did not fare that well either - it failed on sensitivity!

But the Risk Benefit Analysis favoured approval - that was just recently, on the 25th of May 2023!

The BAR for approval is low!

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i don't think you understood what I was referring to. It was more in reference to having a same day scan vs next day scan and the pros and cons of it, if the hypothetical efficacy was not a factor.

Originally posted by ttppxx: ↑

ILLUCCIX & GOZELLIX (Telix) versus PYLARIFY (Latheus)
Covering;
Half lives & Shelf lives
Image acquisition timeframes
What management of Lantheus are saying about perceived logistics advantages
How Cu64 solves problems highlighted by Lantheus

ILLUCCIX & GOZELLIX

Per product labels (FDA);
Gozellix allows for an extension of the Ga68-PSMA-11 product shelf-life by 2 hours (from 4 to 6 hours) - as shown below.
The image acquisition timeframes are identical.

The radiolabelling of Illuccix and Gozellix is still done at Radiopharmacies (like Cardinal), after which the product must be transported to the hospital that needs it.
Questions: How far can it reach? How much radiation activity will the product have at later time points? How good is image quality, if used at later time points? Whats the sensitivity when used that late?

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PYLARIFY (LANTHEUS)
Pylarify has a shelf-life of 10 hours (longer than tha max that Gozellix allows

Pylarify is produced in cyclotrones and its half life does allow some shipments to reach some places that do not have a cyclotrone! But Pylarify is still limited - the half life is 110 minutes, and its shelf life is 10 hours.

But, even with the shelf-life that is longer than that for Illuccix and even Gozellix, the Lantheus management have bemoaned the challenges with trying to get the product to where its needed! Here are some quotes from the Lantheus management in the recent calls - highlighting some strengths as well as some weaknesses;
On Central production: “Our radiopharmacy network and central manufacturing model are key enablers of our commercial success.” (Brian Markison, CEO, Q4 2024)
On reliable deliveries: “We continue to see broad demand for Pylarify across both large institutions and regional imaging centers, driven by our ability to reliably meet delivery expectations.” (Paul Blanchfield, President, Q1 2025)
On the regional/rural gap: “Growth is particularly strong among smaller and mid-sized centers that previously struggled with access to PSMA PET imaging.” (Amanda Morgan, CCO, Q1 2025)
On half-life enabling manufacturing leverage: “We have a longer half-life… a distribution advantage… enables us to optimize our multi-partner manufacturing facility network.” (Amanda Morgan, Q4 2024)
Admission: Pylarify can’t always show up on time: “There are select markets where there is limited access to Pylarify in early mornings or late afternoon.” (Amanda Morgan, CCO, Q4 2024)

CLARITY'S 64Cu-Sar-bisPSMA
If a longer half-life is an advantage (as Lantheus are saying), then Cu-64 has a a lot of it!
If a longer shelf-life is an advantage (as Telix appear to be indicating) then, Cu-64 has a a lot of it!
If centralized manufacture and distributiois an advantage (as Lantheus are saying), then Cu64 is suitable for it, with no need for hot labs everywhere.“Red-eye flights replace radiopharmacies.”
Unlike Pylarify, previous day delivery of Cu64 products means that patients can be scheduled for morning, afternoon, or even next-day.
More and more sites and towns that don't have in-house radiochemistry can receive product by plane and/or courier!
All before the case of speriority - which is not guaranteed, but indications suggest will be achieved!

FDA Approval is not guaranteed either, but lessons from other approvals suggest that, on efficacy and safety, this product will pass!

FURTHER READING
NDA Multi-Disciplinary Review and Evaluation - NDA 214032 Gallium Ga 68 PSMA-11 Injection.pdf
Gozellix Label.pdf
NDA Multi-Disciplinary Review and Evaluation - NDA 212643, Gallium Ga 68 PSMA-11 Injection.pdf
Pylarify label.pdf
Illuccix label.pdf
Pylarify FDA revew.pdf

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i stand corrected. I assumed the telix guys who came here knew their product well. A 6 hr shelf life is still very limited, especially compared to 24hr shelf life of cu64.