Radiopharmaceutical Case Study: Pluvicto | From Approval to Access—Why Clinical Results Alone Do Not Determine Value

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For radiopharmaceuticals, regulatory approval is only the beginning of value realization.

The development of Pluvicto shows that whether a radiopharmaceutical can truly reach patients depends not only on its approved indications, but also on manufacturing and distribution, site readiness, diagnostic screening, and patient referral pathways.

Initial approval: Opening the door to clinical use

In March 2022, Pluvicto received its first FDA approval for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had previously received androgen receptor pathway inhibitor therapy and taxane-based chemotherapy.

This approval also established a clearer clinical and regulatory pathway for PSMA-targeted radioligand therapy.

Indication expansion: A broader patient population brings greater execution demands

In March 2025, the FDA expanded the indication for Pluvicto to include patients with PSMA-positive mCRPC who had received ARPI therapy and were considered appropriate to delay taxane-based chemotherapy.

In July 2026, Pluvicto in combination with an ARPI was further approved for patients with PSMA-positive metastatic hormone-sensitive prostate cancer—referred to by the FDA as metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMN/S)—moving the treatment into an earlier disease setting.

A larger eligible population also increases the need for broader site coverage, efficient patient referrals, and precise treatment coordination.

Manufacturing and distribution: The supply network is part of the product

Radiopharmaceuticals are highly time-sensitive. Manufacturing, quality release, transportation, patient scheduling, and administration must be closely coordinated.

Since its launch, Pluvicto has continued to expand its radioligand therapy manufacturing network, adding production capacity to improve delivery efficiency and supply resilience.

For radiopharmaceuticals, the distance between manufacturing sites and patients—and whether each dose arrives on schedule—can be just as important as regulatory approval.

Diagnosis and referral: An eligible patient is not necessarily an accessible patient

Patients must be selected for Pluvicto using an approved PSMA PET imaging agent based on PSMA expression in their tumors. They must then be referred from their existing care team to a qualified treatment center.

The official US Pluvicto website currently lists more than 700 treatment centers, supported by an access network that connects imaging-based screening, specialist referrals, treatment scheduling, and patient support.

The Pluvicto case demonstrates that realizing the value of a radiopharmaceutical requires alignment across product registration, supply chains, site capabilities, and patient pathways.

Before entering China, developers should assess patient screening and referral pathways, site readiness, supply-to-administration coordination, and consistency of multicenter execution at an early stage.

With 23 years of clinical research experience, more than 2,300 projects, and over 200 multinational clinical trials, GCP ClinPlus provides integrated support across China development strategy, site screening and feasibility, patient pathway planning, clinical operations, data management, and biostatistics.