FDA shared on LinkedIn:
“Today, FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).
The prescribing information includes warnings and precautions for the risk of radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility.
Learn more in the FDA-approved prescribing information at: Drugs@FDA: FDA-Approved Drugs.”
To which Michael Hofman, Nuclear Medicine Physician at Peter MacCallum Cancer Centre, added:
“Terrific news for patients from the FDA today.
Nearly a decade ago we ran the first prospective phase 2 trial of Lu-177 PSMA-617 at Peter MacCallum Cancer Centre, followed by the ANZUP-led randomised TheraP trial, when this was still very much an unproven idea.
Huge credit to the patients who participated in trials, and to the investigators, physicists, radiochemists, technologists and nurses across many countries (especially the pioneers in Germany) who built the evidence.
And for industry for making it available at scale.
A shoutout to supporters who enable us to work on the next generation theranostics: Prostate Cancer Foundation, ANZUP Cancer Trials Group Limited, Prostate Cancer Foundation of Australia, Movember, National Imaging Facility, Australian Cancer Research Foundation.
Don’t miss ProsTIC Theranostics ProsTIC26 Sep 3-5 in Melbourne – we will deep dive on use in hormone-sensitive prostate cancer.
Register Now: 3 – 5 September, 2026, Sofitel Melbourne on Collins.”
Neeraj Agarwal, Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute (HCI), shared on X:
“Just in today U. S. FDA approved Pluvicto (Lutetium-177) for PSMA+ metastatic androgen pathway modulation-sensitive prostate cancer (mAPMS/mHSPC), based on the results of ph3 PSMAddition trial.
Congrats Scott Tagawa and team.”
To which Shilpa Gupta, Director of Genitourinary Oncology at the Cleveland Clinic, added:
“Proud to be part of the PSMA Addition team and our site Cleveland Clinic MD to be the highest-enrolling U.S. site!
Great to have this as an option for patients and deepest thanks to our patients, families, co-investigators and reserach teams who made this possible.”
Karine Tawagi, Assistant Professor of Clinical Medicine and Fellowship Program Director at the University of Illinois Chicago, shared on X:
“FDA approval of Pluvicto triplet vs ADT/ARPI for mCSPC (APMS) PSM Addition
- rPFS: HR 0.72
- time to mCRPC: HR 0.70
- similar QoL
OS data immature wide eligibility criteria for PSMA vs chemo or other triplets (PARP/AKT).
Exciting year for GU onc!”
Katy Beckermann, Medical Director of GU Clinical Research at Tennessee Oncology, shared on LinkedIn:
“Radioligand therapy just entered the first-line setting in prostate cancer.
The FDA approved Pluvicto (177Lu-PSMA-617) in combination with an ARPI for PSMA-positive metastatic hormone-sensitive prostate cancer.
From the Phase 3 PSMAddition trial:
- Primary endpoint met: radiographic PFS favored Pluvicto + standard of care (HR 0.67; 95% CI 0.55–0.82, a 33% risk reduction)
- Overall survival is still maturing (HR 0.80; 95% CI 0.63–1.01), not yet significant
- Grade ≥3 adverse events 50.7% vs 43.0% with standard of care alone
- The approval nearly doubles the Pluvicto-eligible population by moving beyond mCRPC
Why this matters for your practice: Frontline space getting crowded with OS benefit triplet docetaxel, BRCA2+ PARP inhibition, and two MOAs PI3K inhibition and PSMA RLT showing rPFS benefit.
The eligible population just roughly doubled. Imaging access, isotope supply, and radiation-safety workflows will have to keep pace.
Source: Novartis media release, FDA approval of Pluvicto for PSMA+ mHSPC (PSMAddition, Phase 3), July 31, 2026.”
Victor Bultó, President of Novartis US, also shared on LinkedIn:
“Today marks a meaningful step forward in the treatment of metastatic prostate cancer.
This FDA approval expands the use of our radioligand therapy, enabling patients at an earlier stage of the disease to receive it.
For people living with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), the risk of disease progression is a constant concern.
Advancing innovative treatment options into earlier settings is critical to improving outcomes and offers new hope at a pivotal moment in the care journey.
This progress reflects years of scientific commitment and collaboration. I’m grateful to our teams, investigators and partners in this journey, and most importantly to the patients and families who made this research possible.
We’re proud to take another step in reimagining cancer care, and remain focused on pushing the boundaries for patients.
Read more about today’s news: FDA approves Pluvicto® for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC).”
Other articles about prostate cancer on OncoDaily.
