FDA approves Pylarify for diagnosis of advanced/recurrent forms of prostate cancer

In ,a recent media release, Lantheus Holdings announced that the US Food and Drug Administration (FDA) had approved the imaging agent known as piflufolastat F 18 Injection (also known as Pylarify® or more commonly just “PyL”) as a PSMA-based PET imaging agent for identification of prostate cancer.

This agent is actually approved for use in two types of patient: men suspected of having either metastatic or recurrent forms of prostate cancer — even if there is no sign of metastasis on a bone or normal CT scan.

There are now four imaging agents that can be used with PET or of PET/CT scans to identify forms of prostate cancer that may not be easily visible on standard types of scan:

  • The choline C-11 PET/CT scan, used primarily at the Mayo Clinic
  • The Axumin-based PET/CT scan, which is now widely available in the US
  • The gallium-68 PSMA-based PET scan, that is only available at a small number of academic centers and now
  • This newly approved Pylarify-based PET scan

The question now is going to be whether any one of these tests is significantly better than the other three in definable subtypes of patient. At present there is little to no information to show this with accuracy, but Prostate Cancer International profoundly hopes that relevant trials can be conducted to explore this question.

The use of PET scanning in the management of prostate cancer is expensive and restricted to a limited number of centers. It is NOT a technique liable to be available widely in community treatment settings. It will NOT be in the interest of patients if we cannot reach earlky consensus on the most appropriate use of the best of these tests in the right patients.

16 Responses

  1. I think the list of CT/PET agents should have included the standard agent with the tagged glucose molecule that most of us are currently getting. Patients may think they are getting one of these newer agents.

    Most people think that PET scans are all the same.

    It should also be noted that FDA approval does not mean immediate payment by Medicare.

  2. Calais et al., in The Lancet, showed clear superiority of PSMA to fluciclovine F-18 in men with PSA recurrence:

    “detection rates were significantly lower with 18F-fluciclovine PET-CT (13 .., of 50) than with PSMA PET-CT (28 … of 50), …; in the subanalysis of the pelvic nodes region (4) .. with 18F-fluciclovine vs 15 … with PSMA PET-CT …”

  3. There have actually been a couple of comparative studies, testing pairs of radioindicators in the same patients. At the same PSA (0.5-3.5 ng/ml) in recurrent patients, Pylarify detected 88% of cancers whereas Ga-68-PSMA-11 detected 66% of cancers (see here.

    Without a direct comparison in the same patients, we can look at which better detects cancer post-prostatectomy at lower PSA levels. There have been many such “monadic” trials. So far, of the FDA-approved PET radioindicators, the “winners” from most sensitive to least sensitive are:

    — F18-DCFPyL/Pylarify>
    — Ga68-PSMA-11>
    — Fluciclovine / Axumin>
    — C11-Choline/ C-11-Acetate>
    — F18-Choline>
    — NaF18>
    — F18-FDG

    There are some PSMA radioindicators (like F18-PSMA-1007 and F18-rhPSMA-7) that aren’t appreciably cleared by the kidneys that will probably have better detection rates because tumors near the urinary tract won’t be obscured.

    I expect that Johns Hopkins will initially produce Pylarify and ship it out to locations in the northeast and southeast.

    The big news for both PSMA radioindicators is that they are FDA-approved for localized prostate cancer. Axumin and C-11 choline are only FDA-approved for recurrent patients. With Medicare and insurance coverage anticipated, this opens the door to potential replacement of bone scans/CT to rule out distant metastases in such patients.

  4. Alas … I do not understand this comment. I am not aware of any “tagged glucose molecule” that can be used accurately along with a PET scan to diagnose prostate cancer.

  5. Unfortunately, it is not clear from the abstract of the paper by Calais et al. which PSMA test they were using (there are many in development) to compare it to fluciclovine F-18 (Axumin).

  6. The title of the Calais study has the details:
    Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery (PSMA vs AXUMIN)

  7. Sorry, I was not clear in what I meant. The standard PET that most of us get is 18F-Fluoro-deoxy-glucose (FDG)-PET.

    Alan Edel answered this in an earlier reply which put the FDG at the very bottom of the list for sensitivity.

  8. dendoc means FDG (which shows glucose uptake). The Calais paper compares Ga-68-PSMA-11 (it’s in the title) to fluciclovine in the same patients.

  9. Any idea as to how long it might take to get Medicare coverage for Pylarify? Perhaps using the recently approved Gallium compound as an example?

  10. That is going to depend on which Medicare subcontractors are asked to address this particular question first.

  11. Encouraging research news as this protocol could be more available in more locations than Ga68-PSMA-11 once it gets coverage. I had the Ga68-PSMA-11 back in Nov. 2020 after the trials but before FDA approval and paid out of pocket (not a insignificant amount). It was only available at two university locations on the West Coast as of then.

    I consider it well worth it as the Axumin PET scan did not detect any metastasis but the Ga68 scan did. which aided the radiation oncologists and medical oncologists in determining the best treatment protocol fpr me.

  12. I left an earlier comment a few weeks ago … perhaps I don’t have the ability to post. … I do have a further question however..

    In the press release they say it will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the US by year end.

    Do we know if this is available anywhere currently? And any timeframe for when it will be available?

  13. Dear Jerry;

    All that I can call you is the same as what it says in the media release. However, there is now a Pylarify web site available. That web site carries a phone number (8‌44-3‌39-8574) for information for patients about reimbursement and related information. You could try calling that number.

    I am not aware that we ever received a prior comment from you.

  14. It is available at Johns Hopkins (Baltimore), where it was developed. From there it can be shipped to the mid-Atlantic and southeast if arrangements have been made. There will eventually be synthesis labs set up throughout the US, as there are for all the other F18-based radioindicators.

  15. Hi Allen,

    Good to see your name. … I don’t travel these parts too often … but this site is the best … even has an awesome sitemaster….

    I called Johns Hopkins (their imaging dept) and they said they aren’t doing it yet … and they told me it seemed ironic since they were so involved in the trials, etc. …. If you know of a better contact that would be great.

    I’ve called the Pylarify phone number several times … left multiple phone messages and emails … but no return call yet. … It’s early … I get that ….

    I’ll keep trying multiple locations…but I think it will take some time to get up and running…


  16. Mark Markowski is the PI of this trial at Johns Hopkins, which is still recruiting patients.

    You can also try Steven Rowe at Johns Hopkins. Peter Choyke is still running trials at the NIH.

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