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  6. FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
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FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

On July 31, 2026, the Food and Drug Administration 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).

Patients with mAPMN/S prostate cancer should be selected for Pluvicto using Locametz (active ingredient gallium Ga 68 gozetotide) or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.

Full prescribing information for Pluvicto will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in PSMAddition (NCT04720157), a randomized, multicenter, open-label trial in patients with PSMA-positive mAPMN/S prostate cancer. Patients were randomized (1:1) to receive either lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for 6 doses) in combination with an ARPI (n=572) or an ARPI alone (n=572). The administered ARPI per investigator’s choice included abiraterone, apalutamide, enzalutamide, darolutamide, or another ARPI. Treatment with ARPI in both arms could be continued until progressive disease or unacceptable toxicity. Patients received a gonadotropin-releasing hormone agonist or antagonist concurrently or had a bilateral orchiectomy.

The major efficacy outcome measure was radiographic progression-free survival (rPFS) as determined by blinded independent central review (BICR) per Prostate Cancer Working Group 3-modified RECIST v1.1 criteria. Overall survival (OS) was an additional efficacy outcome measure. The trial demonstrated a statistically significant improvement in rPFS in patients treated with lutetium Lu 177 vipivotide tetraxetan and an ARPI compared to an ARPI alone. Median rPFS was not reached in either arm (hazard ratio 0.72 [95% CI: 0.58, 0.90]; p-value 0.002). The OS data were immature at the current analysis.

Adverse reactions were consistent with prior experience with lutetium Lu 177 vipivotide tetraxetan. The prescribing information includes warnings and precautions for the risk of radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility.

Recommended Dosage

The recommended lutetium Lu 177 vipivotide tetraxetan dose in combination with ARPI is 7.4 GBq (200 mCi) every six weeks for six doses, or until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application one month ahead of the FDA goal date.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X @FDAOncology. 

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