Update: FDA grants Priority Review for 177Lu-PSMA-617 for patients with metastatic castration-resistant

[GregHouston]

FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

Sep 28, 2021 Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1.

Priority Review is based on positive data from the pivotal, Phase III VISION study showing 177Lu-PSMA-617 plus standard of care (SOC), significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC compared to SOC alone2

Two additional studies with 177Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating clinical utility in the pre-taxane setting (PSMAfore(link is external)) and in the metastatic hormone-sensitive setting (PSMAddition(link is external))3,4

The FDA previously granted Breakthrough Therapy designation for 177Lu-PSMA-617 for the treatment of mCRPC. Data from the VISION study were published in The New England Journal of Medicine (NEJM)2. Novartis is also evaluating additional opportunities to investigate 177Lu-PSMA-617 in earlier stages of prostate cancer.

[lewicki]

They are just trying to catch up with the rest of the world.How long for AC-225??

Five years ?

[CAMPSOUPS in reply to lewicki]

Better than not at all. I prefer to see it as a positive.Thanks Greg Houston for the update on good news.

[lewicki in reply to CAMPSOUPS]

Absolutely a positive. We just take longer.

[Fightinghard]

Any thoughts on how soon after fda approval that medicare would add the 177 to its approved therapy lists?

[j-o-h-n]

Good News for a change.......Thank you Gregory........

Good Luck, Good Health and Good Humor.

j-o-h-n Saturday 10/02/2021 8:40 PM DST

[NWLiving]

I’m a hoping it’s ready to go when Bill needs it.

[CAMPSOUPS]

Selling is not allowed on HealthUnlocked.BTW "looks like" ?

[GregHouston in reply to CAMPSOUPS]

Nope, not selling anything. Knowledge can be a powerful tool when seeking treatment options.

[CAMPSOUPS in reply to GregHouston]

Sorry to see confusion. My "selling" reply was to Bigfrank as he is promoting a center in Asia and has given out an email address to obtain a "miracle" supplement to acquire said supplement which he hasn't named from.

[GregHouston in reply to CAMPSOUPS]

Oh, got it! Thank you, my friend, for letting me know.

[GregHouston]

No, this drug is not Provenge.