On November 5, Novartis announced that its radioligand therapy (RLT) drug Pluvicto (lutetium [177Lu] vipivotide tetraxetan) received simultaneous approval from China's National Medical Products Administration (NMPA) for two indications:
Adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed after androgen receptor pathway inhibitors (ARPIs) and are suitable for delayed chemotherapy.
2.Adult patients with PSMA-positive mCRPC who have progressed after ARPIs and taxane-based chemotherapy.
Key Highlights:
•Pluvicto was first approved by the FDA in 2022 for third-line treatment of PSMA-positive mCRPC.
•In the first three quarters of 2025, it achieved sales of $1.389 billion (≈¥9.9 billion), making it a blockbuster nuclear medicine drug in Novartis' portfolio.
Approval Based on Global & Chinese Clinical Studies:
The approvals were supported by:
•The global Phase III VISION study
•The PSMAfore study
•Corresponding Chinese bridging studies
1. VISION Study (Global Phase III, Randomized, Open-Label)
•Population: PSMA-positive mCRPC patients who had received ARPIs and taxane chemotherapy.
•Findings: Compared to best standard of care (bSOC) alone, lutetium [177Lu] vipivotide tetraxetan + bSOC significantly improved:
•Radiographic progression-free survival (rPFS)
•Overall survival (OS)
2. PSMAfore Study (Global Phase III, Randomized, Open-Label)
•Population: mCRPC patients who had received one ARPI but no chemotherapy.
•Findings: Lutetium [177Lu] vipivotide tetraxetan showed:
•6-month longer rPFS (11.60 months vs. 5.59 months, HR 0.49, P<0.001) vs. switching to another ARPI.
Higher objective response rate (ORR 50% vs. 15%) (among patients with measurable lesions).
Higher complete response (CR 21% vs. 4%) & PSA50 response rate (51% vs. 17%).
Future Potential:
Novartis is exploring earlier-line prostate cancer treatments with this drug.
PSMAddition (Phase III for metastatic hormone-sensitive prostate cancer, mHSPC) presented at ESMO 2025 met its primary endpoint, reducing radiographic progression or death risk by 28% (HR 0.72, p=0.002).
Market Impact: Prostate Cancer Dominates Male Drug Sales
•From 2016 to H1 2025, 7 out of the top 10 best-selling male drugs in China's public healthcare system were for prostate cancer treatment, highlighting the heavy disease burden.
•Novartis' Pluvicto approval in China will advance precision prostate cancer therapy, offering new hope for patients.
Data Source: Yaozhi Data
|
Serial Number
|
Drug
|
Cumulative Sales (in billions of yuan)
|
Corresponding Male Diseases
|
|---|---|---|---|
|
1
|
Goserelin Acetate Sustained-Release Implant
|
248.51
|
Hormone-sensitive prostate cancer
|
|
2
|
Docetaxel Injection
|
231.27
|
Hormone-refractory metastatic prostate cancer
|
|
3
|
Leuprorelin Acetate Microspheres for Injection
|
217
|
Prostate cancer
|
|
4
|
Paclitaxel Injection
|
112.5
|
Seminoma
|
|
5
|
Leuprorelin Acetate Sustained-Release Microspheres for Injection
|
87.57
|
Prostate cancer
|
|
6
|
Finasteride Tablets
|
80.33
|
Benign prostatic hyperplasia; Androgenetic alopecia in men with enlarged prostate
|
|
7
|
Bicalutamide Tablets
|
78.13
|
Prostate cancer
|
|
8
|
Tamsulosin Hydrochloride Sustained-Release Capsules
|
74.02
|
Benign prostatic hyperplasia
|
|
9
|
Abiraterone Acetate Tablets
|
67.32
|
Castration-resistant prostate cancer
|
|
10
|
Triptorelin Acetate for Injection
|
61.48
|
Prostate cancer
|
Data Source: Yaozhi Data
