FDA expands Pluvicto approval for earlier-stage metastatic prostate cancer treatment

On July 31, 2026, the FDA expanded its approval of Novartis' radioligand therapy Pluvicto to treat patients with PSMA-positive metastatic hormone-sensitive prostate cancer. This decision nearly doubles the eligible patient pool. The approval is supported by the Phase III PSMAddition trial, which showed a 33% reduction in the risk of progression or death. However, patients face logistical hurdles, as Pluvicto must be administered at licensed nuclear medicine facilities and requires strict post-treatment household radiation precautions.

Pluvicto approval expansion

• ▪Pluvicto was previously approved by the FDA as a post-chemotherapy treatment for PSMA-positive metastatic castration-resistant prostate cancer.
• ▪The FDA approved Pluvicto in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer on July 31, 2026.
• ▪The expanded FDA approval allows Pluvicto to be used across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population.

PSMAddition trial results

• ▪The PSMAddition trial demonstrated a positive overall survival trend favoring the Pluvicto combination with a hazard ratio of 0.80, though final overall survival data remain immature.
• ▪An updated analysis of the PSMAddition trial showed the Pluvicto combination reduced the risk of progression or death by 33% compared to standard of care alone.
• ▪Grade 3 or higher adverse events occurred in 50.7% of patients receiving the Pluvicto combination in the PSMAddition trial, compared to 43.0% in the standard of care control group.
• ▪In the Phase III PSMAddition trial, adding Pluvicto to standard of care reduced the risk of radiographic progression or death by 28% at the primary analysis.

Treatment facility constraints

• ▪Pluvicto can only be administered at facilities holding a radioactive materials license with appropriately trained nuclear medicine staff.
• ▪The Pluvicto treatment regimen requires patients to receive one intravenous dose every six weeks for up to six doses, spanning roughly 30 weeks of scheduled travel.

PSMA PET scan requirement

• ▪Patients must undergo a PSMA PET scan using an FDA-approved imaging agent to confirm tumor PSMA expression before receiving Pluvicto.
• ▪The PSMA biomarker is present in more than 80% of prostate cancer patients.

Manufacturing capacity questions

• ▪Novartis states it has five radioligand therapy manufacturing sites operational or under construction in the United States and can deliver Pluvicto within five days of an order.
• ▪Novartis has received FDA clearance for commercial manufacturing of radioligand therapies at facilities in Millburn, New Jersey, and Indianapolis, Indiana.

Household radiation precautions

• ▪Pluvicto prescribing information advises patients to limit close contact within three feet with household members for two days, and with children and pregnant women for seven days.
• ▪Pluvicto prescribing information recommends separate sleeping arrangements from household contacts for three days, from children for seven days, and from pregnant women for 15 days.