Novartis’s radioligand therapy drug Pluvicto® is approved in China for a new indication in the treatment of patients with metastatic hormone-sensitive prostate cancer

Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) was fully approved* for three major indications, benefiting a wider range of Chinese prostate cancer patients

Novartis announced today that the National Medical Products Administration (NMPA) has approved the radioligand therapy (RLT) drug Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) in combination with an androgen receptor pathway inhibitor (ARPI) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).

This approval marks that the clinical application of Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) in China has further moved from metastatic castration-resistant prostate cancer (mCRPC) to mHSPC, providing innovative treatment options based on PSMA targets for a wider range of prostate cancer patients. Including previously approved in 2025 for two types of PSMA-positive mCRPC patients, namely patients who are suitable for delayed chemotherapy after treatment with ARPI, and patients after treatment with ARPI and taxane-based chemotherapy, Pluvicto® has been approved for three indications in China, covering multiple key treatment stages from mHSPC to mCRPC, before chemotherapy to after chemotherapy, further expanding the potential benefit group.

Li Yao, President and Managing Director of Novartis China, said: "The approval of the new indication of Pluvicto® mHSPC in China is the third prostate cancer indication for Pluvicto® in China. This is a sign that Novartis continues to promote innovation in radioligand therapy and accelerate the development of radioligand therapy in China. This is another important milestone in bringing innovative drugs to Chinese patients. We look forward to continuing to work with the Chinese medical system and industry parties to promote the standardized application of PSMA testing, multidisciplinary diagnosis and treatment, and radioligand therapy, so that innovative treatments can benefit more Chinese prostate cancer patients in a timely and reliable manner.”

The disease burden of prostate cancer in China continues to rise, and there is an urgent need to seize the golden treatment window for mHSPC

Prostate cancer is the malignant tumor with the highest incidence rate in the male genitourinary system in China. According to the latest data from the National Cancer Center (2024), its incidence ranks fifth among male malignant tumors, with approximately 163,900 new cases annually [1] . Compared with European and American countries, a prominent problem faced by prostate cancer patients in China is "late detection". Data show that only about 30% of patients with prostate cancer in China have clinical localization (early stage) when they are first diagnosed, and the proportion of metastatic patients is even higher. About 54% of patients have distant metastasis when they are first diagnosed, and their prognosis is poor [2,3]

mHSPC is a stage where prostate cancer has metastasized far away, but the disease is still sensitive to androgen pathway modulation therapy. Although androgen deprivation therapy (ADT) combined with ARPI has become an important part of the contemporary standard of care, metastatic hormone-sensitive prostate cancer may eventually progress to mCRPC, the end-stage prostate cancer. Once the disease progresses to the mCRPC stage, the patient's risk of disease progression and death will significantly increase. The 5-year survival rate of prostate cancer patients with distant metastasis is only 40.1% [2], and the treatment options available at the mCRPC stage are more limited, and patient survival and quality of life are significantly reduced [3,4]. Therefore, achieving more adequate and durable disease control and delaying radiographic progression and transformation to mCRPC while patients are still in the mHSPC stage are important goals of clinical management.

New indication for radioligand therapy for mHSPC approved, bringing new hope to a wider range of prostate cancer patients

The approval of this new indication for Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) is based on the global multi-center, randomized, open-label Phase III PSMAddition study. The results of this study showed that combined treatment with lutetium [177Lu] vipivotide tetraxetan injection significantly improved radiographic progression-free survival (rPFS) compared with the control group, and reduced the relative risk of radiographic progression or death by 33% (HR 0.67; 95% CI 0.55-0.82) [5].

Subgroup analysis showed that regardless of the baseline disease burden or whether the patient had new or recurrent mHSPC, the rPFS benefit direction of lutetium [177Lu] vipivotide tetraxetan injection combination therapy was consistent with that of the overall population, further supporting its broad clinical application potential in patients with PSMA-positive mHSPC with different clinical characteristics [6]. In terms of safety, the safety profile of lutetium [177Lu] vipivotide tetraxetan injection combination therapy in the PSMAddition study was generally controllable. The most common adverse event was dry mouth (mainly grade 1-2). The study found no unexpected safety signals related to this combination regimen [4].

Professor Ye Dingwei, chief expert of the urologic oncology multidisciplinary team at Fudan University Shanghai Cancer Center, said: "mHSPC does not mean that the disease risk is lower. Once it progresses to mCRPC, the treatment options available to patients will be greatly limited. Therefore, it is of great significance to introduce precision treatment methods in the earlier stages of prostate cancer. The results of this PSMAddition study are exciting, lutetium [177Lu] vipivotide tetraxetan injection combined with ADT and ARPI can significantly delay disease progression in the mHSPC stage, and its safety profile is generally controllable and manageable. This means that eligible Chinese prostate cancer patients can receive precise treatment options based on PSMA targets from the beginning of their metastatic disease diagnosis, which is expected to maintain disease control for a longer period of time and delay the transformation to mCRPC."

Novartis continues to increase efforts to fulfill its long-term commitment to the development of radioligand therapy in China

Novartis has been deeply involved in the field of radioligand therapy since 2017. Together with chemotherapy, biological therapy, gene and cell therapy and xRNA therapy, it constitutes the five major technology platforms that Novartis focuses on. Novartis is currently developing a broad RLT product portfolio and exploring new radionuclides, ligands and combination therapies to expand indications to gastroenteropancreatic neuroendocrine tumors (GEP-NETs), breast cancer, colon cancer, lung cancer and pancreatic cancer. At the same time, Novartis China's radiopharmaceutical production project is accelerating construction in Haiyan, Zhejiang, and is expected to be officially put into production in 2027 to further enhance local production and supply capabilities and accelerate innovative radioligand therapies to benefit more Chinese cancer patients.

About Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection)

Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) is an intravenously administered radioligand therapy (RLT) consisting of a targeting compound (ligand) and a therapeutic radionuclide (radioactive particle, in this case lutetium-177). When injected into the bloodstream, it binds to target cells that express PSMA, a transmembrane protein, including prostate cancer cells. Upon binding, the energy released by the radioactive isotope can damage the target cell and neighboring cells, disrupt its ability to replicate and/or induce cell death.

Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) has been fully approved for three major indications. The aforementioned "comprehensive" means that this product has been approved for the following adult patients: PSMA-positive mCRPC whose disease has progressed after receiving ARPI and is suitable for delayed chemotherapy; PSMA-positive mCRPC whose disease has progressed after receiving ARPI and taxane chemotherapy; combined with ARPI to treat PSMA-positive mHSPC.

Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) is currently the only PSMA targeted therapy drug approved to cover metastatic prostate cancer. Novartis is also exploring its use in oligometastatic prostate cancer (PSMA-DC, NCT05939414).

Novartis and radioligand therapy (RLT)

Novartis is reshaping the landscape of advanced cancer treatment through RLT. For the treatment of advanced tumors by delivering therapeutic radiation directly to target cells throughout the body.

As one of the global leaders in this field, Novartis has established integrated capabilities in R&D, manufacturing, logistics, and patient and healthcare support to help ensure that approved RLTs can benefit patients stably and efficiently. Novartis is exploring a broad portfolio of isotopes, ligands and combination therapies to advance RLT applications beyond prostate cancer and neuroendocrine tumors.

About Novartis

Novartis is an innovative medicines company. We work hard to imagine the future of medicine that improves and extends life, empowering patients, healthcare professionals and society as they face the challenges of serious disease. In 2025, our medicines will benefit more than 300 million patients worldwide.

[1] Xia C, et al. Nat Rev Clin Oncol. 2026 Jun 19.

[2] National Cancer Institute. Stat Facts: Prostate Cancer.

[3] National Health Commission of the People's Republic of China, et al. Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 Edition).

[4] Tagawa ST, Sartor O, Piulats JM, et al. [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial. Lancet. 2026; published online August 6. doi:10.1016/S0140-6736(26)01092-5.

[5] Novartis data on file.

[6] Saad F, Tagawa ST, Sartor AO, et al. Subgroup analyses by disease volume and de novo/recurrent mHSPC in the PSMAddition study of [177Lu]Lu-PSMA-617. J Clin Oncol. 2026;44(16_suppl):5020.

statement

This material is intended to convey cutting-edge medical information, regulatory trends and related research progress, and is not for advertising purposes. The disease and treatment information contained in this article is for reference only and does not substitute for diagnosis or treatment advice from a health care professional. Please follow the advice or guidance of your doctor or other health care professional.