Pluvicto enters clinical use in Korea amid growing interest in radioligand therapy for prostate cancer

Novartis' Pluvicto, a next-generation radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC), has begun clinical use in Korea following regulatory approval, offering new hope to patients with limited treatment options.

Although not yet reimbursed under the national health insurance system, the drug’s early adoption at major tertiary hospitals signals a growing interest in precision oncology driven by radiopharmaceuticals.

Novartis Korea held a media session on Tuesday at its Yeouido headquarters to discuss the clinical significance and implementation challenges of Pluvicto, which received regulatory approval from the Ministry of Food and Drug Safety in May last year.

Pluvicto targets prostate-specific membrane antigen (PSMA), a protein overexpressed in aggressive and treatment-resistant prostate cancer. The drug combines a PSMA-targeting ligand (PSMA-617) with the radioactive isotope lutetium-177 to deliver cytotoxic radiation directly to cancer cells. The mechanism not only allows for selective destruction of PSMA-positive tumor cells but also enables real-time imaging of therapeutic uptake via PSMA PET-CT scans.

“Pluvicto exemplifies the future of precision oncology, delivering radiation only to the tumor sites identified in pre-treatment imaging,” Professor Lee Dong-yoon of the Department of Nuclear Medicine at Asan Medical Center said. “It brings the concept of theranostics -- diagnosis and therapy in one continuum -- into routine prostate cancer management.”

The approval of Pluvicto was based on the global phase 3 VISION trial, which enrolled 831 patients with PSMA-positive mCRPC who had previously been treated with both androgen receptor pathway inhibitors (ARPIs) and taxane-based chemotherapy.

The study showed that adding Pluvicto to standard care significantly improved clinical outcomes compared to standard therapy alone. The radiographic progression-free survival (rPFS) was 8.7 months in the Pluvicto arm versus 3.4 months in the control group, while overall survival (OS) was extended to 15.3 months from 11.3 months. Pluvicto reduced the risk of disease progression or death by 60 percent.

Professor Park In-keun of the Department of Oncology at Asan Medical Center, emphasized the practical relevance of these findings for Korea’s aging cancer population.

“More than 70 percent of patients with mCRPC are elderly and physically vulnerable,” he said. “For these patients, who are often ineligible for aggressive chemotherapy, Pluvicto offers a realistic and effective alternative.”

Park added that although side effects such as dry mouth, fatigue, or hematologic abnormalities were observed, most were manageable and did not require discontinuation.

“It’s a tolerable regimen even for frail patients, and the quality-of-life gains are meaningful,” he said.

Despite its promise, widespread adoption of Pluvicto in Korea faces infrastructural and policy hurdles.

As a radiopharmaceutical, it requires not only PSMA PET-CT imaging capacity but also facilities for radioactive drug handling, specialized personnel, and patient isolation areas. Interdisciplinary collaboration among nuclear medicine, oncology, radiology, pathology, and urology departments is also essential for safe and effective administration.

“Pluvicto is a high-purity radioactive agent and can only be administered at hospitals with certified nuclear medicine departments and proper radiation handling licenses,” Lee said. “Its use is impossible without a multi-departmental setup and robust institutional backing.”

The biggest barrier for patients is that the drug is not reimbursed in Korea, and patients must bear the full cost.

Pluvicto costs about 37 million won ($26,977) per single treatment. As the standard course involves up to six cycles administered every six weeks, the total cost of completing the full regimen can reach 222 million won.

However, while Novartis has initiated discussions for pricing and coverage, Lee stressed that any decision must also account for the complexity of care delivery.

In clinical practice, administering Pluvicto is far more complex than delivering conventional systemic therapies.

Before treatment can begin, patients must undergo a PSMA PET-CT scan to confirm target expression, which itself requires specialized imaging infrastructure. Once eligibility is established, the hospital must coordinate radiopharmaceutical compounding under strict radiation safety protocols, secure a shielded administration room, and allocate trained staff -- including nuclear medicine physicians, radiopharmacists, technologists, and radiation safety officers.

Furthermore, each treatment session involves detailed quality control of the radioactive agent, patient preparation and monitoring, radiation exposure management, and post-treatment follow-up, including imaging to confirm drug uptake and adverse event monitoring.

“These are not routine procedures that any oncology center can carry out,” Lee added. “The clinical and logistical burden on nuclear medicine departments is substantial, and without appropriate procedural reimbursement, many hospitals may hesitate to offer the treatment even if the drug itself becomes reimbursed.”

As a result, if the government considers reimbursement, compensation for these clinical efforts must be part of the package, Lee added.

Still the two cancer clinical experts agreed that therapeutic options for post-ARPI or post-taxane patients remain insufficient.

With PSMA expression detectable in most mCRPC cases, Pluvicto may fill a critical gap, particularly for patients who are resistant to or unfit for existing therapies.

“Pluvicto is not just another drug, it’s a platform therapy that represents a broader shift toward molecularly guided cancer care,” Park said. “Its success could catalyze the introduction of other radioligand therapies in Korea, provided we build the right clinical and policy ecosystem around it.”