New Radiation Treatment for Hormone-Sensitive Metastatic Prostate Cancer

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand given as an intravenous injection. On the US Prescribing Information (major change July 2026) it is indicated in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.

This is a traditional FDA supplemental approval of a product first approved in 2022. Overall survival data from the new-use trial were immature at the analysis used for approval.

Distinct path — not this carton (fact-only): The older Pluvicto door for metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer after ARPI (and with or without prior taxane) remains a separate labelled use. Other prostate radioligands, chemotherapy, and ARPI-alone care have separate labels. Today’s US labelled earlier-line radioligand door with ARPI for PSMA-positive mAPMN/S prostate cancer is Novartis Pluvicto (NDA 215833 family, sNDA July 2026).

The FDA approved this expansion on 31 July 2026. Applicant: Novartis Pharmaceuticals Corporation. Review conducted under Project Orbis with the UK MHRA; FDA states application reviews are ongoing at the other regulatory agencies — that is not a confirmed foreign licence. USPI Recent Major Changes: Indications and Usage (1.1), Patient Selection (2.2), Recommended Dosage (2.3), Myelosuppression (5.2), and Renal Toxicity (5.3) — 7/2026. Distributed by Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. Document code T2026-26.

Where this is taking place

Commercial labelled door today: United States — FDA-labelled Pluvicto for adults with PSMA-positive mAPMN/S prostate cancer, given at a centre licensed to handle radiopharmaceuticals, after PSMA PET selection (Locametz or another approved PSMA PET product), together with an ARPI and a GnRH analog (or prior bilateral orchiectomy). Company materials describe Novartis Patient Support for insurance, referral, ordering, and navigation help for eligible patients. This is a genitourinary oncology / nuclear-medicine radioligand conversation — not a retail pickup and not a DIY import.

Outside the United States: As of this draft, no confirmed Health Canada, European Commission, MHRA, TGA, Swissmedic, or PMDA/MHLW marketing authorisation for this mAPMN/S use. Existing foreign Pluvicto licences, if any, for later-line castration-resistant disease are not this expansion. Project Orbis ≠ a licence. Do not import on your own.

PSMAddition — NCT04720157 — Randomized, open-label, multicenter Phase 3 study. Lead sponsor: Novartis Pharmaceuticals. CT.gov status at draft time: ACTIVE, NOT RECRUITING. Actual enrolment 1140 (USPI efficacy N=1144 randomized). Actual start 9 Jun 2021; actual primary completion 13 Jan 2025; estimated study completion 11 Feb 2027. Countries with listed sites include the United States, Canada, United Kingdom, France, Germany, Spain, Japan, China, and others. Expanded access: CT.gov reports hasExpandedAccess: false on the record retrieved for this draft. Honesty: Follow-up for overall survival continues — that is not open new-enrolment for the pivotal cohort, and it is not the same sentence as “walk into any clinic for this new use.”

The practical commercial door in the US is a prostate-cancer / nuclear-medicine clinic that can confirm PSMA-positive mAPMN/S disease on an approved PET scan, write labelled Pluvicto with an ARPI and ADT, manage radiation precautions, blood counts, and kidney tests, and arrange Novartis Patient Support / payer logistics — not treating ACTIVE_NOT_RECRUITING as open enrolment.

Approval matrix

Access by country

• United States: Ask a genitourinary oncology / nuclear-medicine clinic about FDA-labelled Pluvicto for this earlier door. Labelled 31 July 2026 in combination with an ARPI for adults with PSMA-positive mAPMN/S prostate cancer. Select patients with Locametz or another approved PSMA PET based on PSMA expression in tumors. Recommended dosage: 7.4 GBq (200 mCi) IV every 6 weeks for 6 doses, or until progression or unacceptable toxicity; continue ARPI per that product’s prescribing information; give a GnRH analog concurrently unless the patient has had bilateral orchiectomy. Handle as a radiopharmaceutical. Vial in lead-shielded container: NDC 0078-1217-61; 1,000 MBq/mL (27 mCi/mL) at calibration; 7.4 GBq ± 10% at administration; shelf life 120 hours (5 days) from calibration. Company support: Novartis Patient Support (Start Form fax 1-844-638-7329 on company HCP materials; program line 1-844-638-7222 on those materials). Suspected adverse reactions: Novartis 1-888-669-6682 or FDA MedWatch 1-800-FDA-1088. No list price or copay dollars in this article. This is US commercial labelled radioligand supply through specialist centres, not a DIY import.

• Canada: This mAPMN/S Pluvicto authorisation is not confirmed. Ask the Canadian GU oncology clinic what legal paths exist in Canada when a Canadian label for this earlier use does not yet exist. A later-line Canadian carton, if present, is not this expansion.

• European Union / United Kingdom / Australia / Japan / other countries: Regulator authorisation for this mAPMN/S use is not confirmed in this draft. Open or completed trial sites are not a commercial foreign carton for the new use. Do not import on your own.

• If your regulator has not authorised this use: do not import on your own. Ask the local clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting — without treating a US vial as a foreign carton for this expansion.

Who is eligible (from the US label)

This is an adult PSMA-positive mAPMN/S prostate cancer conversation on the Prescribing Information — radioligand plus ARPI — not a claim that overall survival benefit is already proven for this door, and not a collapse into the older castration-resistant carton.

United States (USPI, major changes July 2026):

• Indication (this draft): In combination with ARPI for adults with PSMA-positive mAPMN/S prostate cancer.
• Patient selection: Locametz or another approved PSMA PET based on PSMA expression in tumors.
• Recommended dosage (mAPMN/S): 7.4 GBq (200 mCi) every 6 weeks for 6 doses, with ARPI, until progression or unacceptable toxicity.
• Contraindication: None listed on Highlights.
• Warnings: Risk from radiation exposure (hydration, frequent voiding, contact restrictions after dosing); myelosuppression (CBC monitoring; withhold / reduce to 5.9 GBq once / discontinue); renal toxicity (kidney labs; hydration); embryo-fetal toxicity (effective contraception during treatment and for 14 weeks after last dose for males with female partners of reproductive potential); infertility (temporary or permanent).
• Most common pooled adverse reactions including laboratory abnormalities (≥20% across PSMAddition, PSMAfore, and VISION; N=1320): decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased eGFR, increased AST, decreased sodium, increased magnesium, increased potassium, decreased calcium, increased alkaline phosphatase.
• PSMAddition (this door) all-grade events more common with Pluvicto+ARPI than ARPI: fatigue 51% vs 41%, dry mouth 46% vs 3.7%, nausea 34% vs 9%. Serious adverse reactions 32%; fatal adverse reactions 2.7%; permanent discontinuation 8%.
• Pediatrics: Safety and effectiveness not established (this is an adult prostate-cancer carton).
• Geriatrics: Discuss with clinician; PSMAddition median age 68 years (range 36–91).

PSMAddition trial context (USPI): Adults with PSMA-positive mAPMN/S prostate cancer; at least one metastatic lesion on conventional imaging and at least one lesion with gallium Ga 68 gozetotide uptake greater than normal liver; no systemic treatment except ADT in neo-/adjuvant setting and/or up to 45 days of ADT, ARPI, or both in the metastatic setting before consent. 70% high-volume and 30% low-volume disease. ARPIs used: abiraterone, apalutamide, enzalutamide, darolutamide, or another ARPI.

Not labelled on sources confirmed for this draft:

• This expansion in Canada, the EU, UK, Japan, Australia, or Switzerland (not confirmed here).
• Proven overall-survival benefit for the mAPMN/S door (still immature).
• Treating NCT04720157 follow-up as open commercial enrolment.
• Collapsing mAPMN/S with the older mAPMR / mCRPC Pluvicto carton.

What the pivotal study showed (Prescribing Information)

Use the Prescribing Information for a prescription conversation. Journals are supportive reading.

PSMAddition — NCT04720157 (USPI Study 14.1):

• Randomized 1:1, open-label, multicenter; Pluvicto 7.4 GBq q6wk ×6 + ARPI (N=572) vs ARPI alone (N=572).
• Primary endpoint: rPFS by blinded independent central review (PCWG3-modified RECIST v1.1). OS additional.

USPI Table 11 — Efficacy results:

Trial-status honesty: CT.gov status ACTIVE, NOT RECRUITING at draft time. Delay in radiographic progression ≠ proven overall-survival benefit yet.

How it is taken (US label — keep this exact)

Research team (from primary sources only)

• Applicant / distributor: Novartis Pharmaceuticals Corporation, East Hanover, NJ.
• Pivotal study sponsor: Novartis Pharmaceuticals (NCT04720157 / PSMAddition).
• Patient support (company HCP materials): Novartis Patient Support — Start Form fax 1-844-638-7329; program line 1-844-638-7222.
• AE reporting on USPI Highlights: Novartis 1-888-669-6682.
• Names and phones below are limited to what appears on the Prescribing Information, FDA approval notice, ClinicalTrials.gov, and clearly labelled company support materials.

Sources

1. FDA — FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (31 Jul 2026).
2. Novartis — Pluvicto US Prescribing Information (major changes 7/2026; T2026-26).
3. ClinicalTrials.gov — NCT04720157 (PSMAddition).
4. Novartis — FDA approval company announcement for PSMA-positive mHSPC / mAPMN/S (31 Jul 2026).
5. Novartis Patient Support / PLUVICTO HCP access materials (Start Form / program contacts).

Not medical advice. Talk with a clinician who knows the full history before any treatment decision. Authorized is not funded.