Novartis Korea's prostate cancer treatment, Pluvicto, which has garnered attention since its approval by the Ministry of Food and Drug Safety (MFDS), has now been administered to Korean patients for three months.

Pluvicto is a blockbuster drug that generated over KRW 1 trillion in global sales last year and is recognized as a product initiating the so-called "radioactive missile" era.

Pluvicto can primarily be prescribed in large hospitals in South Korea, leading to a growing number of patients receiving the treatment. However, its high cost and non-reimbursable status remain significant barriers to patient access.

As the use of radiopharmaceuticals becomes more widespread in domestic clinical settings, competition among local pharmaceutical‧biotech companies developing similar treatments is intensifying once again.

According to the medical community on November 14, since the MFDS approved Novartis Korea's prostate cancer treatment Pluvicto (Lutetium (177Lu) vipivotide tetraxetan injection) at the end of May, six medical institutions, including the National Cancer Center, have administered or plan to administer the treatment as of November.

Pluvicto is a radioligand therapy that targets prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer, by binding the radioactive isotope Lutetium-177 (177Lu) to PSMA to eliminate cancer cells. Radioligands are therapies that combine a ligand (a targeting molecule) with a therapeutic radioactive isotope. When the radioligand binds to the target cell, it emits therapeutic radiation, which suppresses cancer cell proliferation.

The basis of domestic approval was the Phase 3 VISION clinical tiral. The trial involved 831 patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). It was designed to compare the efficacy and safety of Pluvicto combined with standard therapy versus standard therapy alone.

The clinical trial results showed that the Pluvicto group recorded a median radiographic progression-free survival (PFS) of 8.7 months, significantly longer than 3.4 months in the control group. The median overall survival (OS) was 15.3 months for the Pluvicto group, compared to 11.3 months for the control group. Administration of Pluvicto reduced the risk of disease progression or death by 60%.

To introduce Pluvicto, medical institutions must have dedicated PSMA PET-CT equipment for prostate cancer and facilities for preparation, quality control, and separate spaces for patient administration. Additionally, multidisciplinary collaboration involving nuclear medicine, oncology, and urology specialists is essential. The treament requires significant investment in medical institutions' facilities, equipment, and personnel.

Currently, 15 medical institutions nationwide, including major hospitals in South Korea, have adopted PSMA PET-CT for diagnostic purposes. As of November, six of these institutions are providing treatment using Pluvicto.

The remaining issue is the cost. The recommended dose of Pluvicto is 7.4 GBq (200 mCi), administered intravenously every six weeks (±1 week) for up to six doses. Each dose costs KRW 30-40 million out-of-pocket in clinical practices, bringing the total treatment cost to approximately KRW 200 million.

However, despite the high cost, the clinical efficacy of Pluvicto has been proven to surpass existing treatments. Nearly 20 patients have completed or are undergoing Pluvicto therapy within three months after launch. Considering the expense, this is a significant number of patients.

Dr. Inkeun Park from the Oncology Department at Asan Medical Center in Seoul said, "From a medical professional's perspective, the introduction of Pluvicto sheds a positive light as it provides an additional effective treatment option with manageable side effects." Park added, "The challenge lies in its high cost, the limited number of institutions equipped to perform PSMA PET-CT, and the restricted availability of facilities capable of administering the treatment."

Novartis, fully aware of these challenges, has set reimbursement for Pluvicto as a chief objective for next year.

A representative from Novartis Korea said, "We are currently conducting internal reviews to secure reimbursement for Pluvicto." Adding, "Given its role in transforming the prostate cancer treatment paradigm, we aim to improve patient accessibility by obtaining reimbursement approval next year."