3/28 Expanded FDA Approval of 177Lutetium-PSMA-617

[kainasar]

Breaking News: Expanded FDA Approval of 177Lutetium-PSMA-617 | Prostate Cancer Foundation

pcf.org/c/breaking-news-exp...

[PCaWarrior]

Thanks. Very valuable information.

Pluvicto now approved for mCRPC after failing ARSIs. No need to have taxane chemo.

I can show that I am CRPC and have failed ARSIs. I don't have the metastatic status though. I have no idea how to "prove" that. Anyone have any ideas?

[kainasar in reply to PCaWarrior]

Check this out healthunlocked.com/advanced...

[PCaWarrior in reply to kainasar]

Thanks. I'm not chomping at the bit. Side effects. But it would be nice if I could somehow prove that I satisfy the insurance requirements so I could get this if I needed.

I was oligometastatic two years ago. And I could show CRPC and ARSI failure at that time. Do you know if that's good enough or would it have to be current proof?

[dhccpa in reply to PCaWarrior]

Yes, I believe there is a high likelihood that will work. Docs and the FDA don't seem to distinguish when one scan contradicts another, even an older one contradicting a newer one. Who wants to draw a line in the sand that a patient is NOT metastatic?

[PCaWarrior in reply to dhccpa]

Thanks.

[dhccpa in reply to PCaWarrior]

Just run some out of date PET scans. They'll show "uptake" somewhere! With your medical history, they'll conclude it's "consistent with prostate cancer." Those old scans serve a purpose.

[PCaWarrior]

The FDA has approved an expanded indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) on March 28, 2025, allowing its use in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients prior to chemotherapy. This approval triples the eligible patient population and is based on results from the Phase III PSMAfore trial.

Key Details of the Expanded Approval

Indication: Pluvicto is now approved for patients with PSMA-positive mCRPC who:

Have been treated with at least one androgen receptor pathway inhibitor (ARPI).

Are considered appropriate to delay taxane-based chemotherapy.

Efficacy:

Reduced risk of radiographic progression or death by 59% compared to a second ARPI (HR=0.41; p<0.0001).

Median radiographic progression-free survival (rPFS): 11.6 months (Pluvicto) vs. 5.6 months (ARPI).

PSA response: 57.6% of patients achieved a ≥50% PSA reduction on Pluvicto vs. 20.4% with ARPI.

Safety:

Common Grade 1-2 side effects: Dry mouth (61%), fatigue (53%), nausea (32%), and constipation (22%).

Pluvicto did not impair the ability to receive subsequent chemotherapy.

Clinical Implications

This approval changes the treatment paradigm for mCRPC by offering a targeted radioligand therapy earlier in the treatment sequence, potentially delaying disease progression more effectively than a second ARPI.