By Fineline Cube 
Novartis (NYSE: NVS) has announced that its Lutetium‑177‑labelled therapy Pluvicto (lutetium ¹⁷⁷Lu‑vipivotide tetraxetan) now holds approvals for two new indications in China, signifying a major expansion of its PSMA‑targeted portfolio in the largest cancer market in the world.
Key Approval Highlights
| Element | Detail |
|---|---|
| Approving Agency | National Medical Products Administration (NMPA) |
| Therapeutic Modality | Radioligand Therapy (RLT) |
| Drug | Pluvicto (lutetium ¹⁷⁷Lu‑vipivotide tetraxetan) |
| Approved Indications | 1. Adult PSMA‑positive metastatic castration‑resistant prostate cancer (mCRPC) patients who progressed after an androgen‑receptor‑pathway inhibitor (ARPI) and are suitable for delayed chemotherapy. 2. Adult PSMA‑positive mCRPC patients who progressed after an ARPI and taxane‑based chemotherapy. |
| Review Status | Both were granted priority review due to the urgency of unmet clinical need. |
Pluvicto is now the only PSMA‑targeted RLT licensed in China, a milestone that broadens therapeutic options for patients who have exhausted standard systemic therapies.
Evidence Basis
The approvals were supported by robust clinical data, including:
- Global Phase 3 VISION Study – Demonstrated a 5.3‑month absolute increase in radiographic progression‑free survival (rPFS) (8.7 months vs. 3.4 months) and a 4‑month OS advantage (15.3 months vs. 11.3 months) for PSMA‑positive patients previously treated with both ARPI and taxane chemotherapy.
- PSMAfore Study – Showed a 6‑month rPFS improvement (11.60 months vs. 5.59 months) in patients who had received one ARPI but had not yet undergone chemotherapy, along with a 35‑point lift in objective response rate (ORR 50% vs. 15% for measurable lesions).
- Chinese Bridging Studies – Conducted in parallel to meet specific population pharmacokinetic and safety requirements mandated by the NMPA.
These results underscore Pluvicto’s best‑in‑class efficacy profile for PSMA‑positive mCRPC in both pre‑ and post‑taxane settings.
Market Implications & Next Steps
- Revenue Growth – China now represents an additional $45‑$60 billion opportunity for PSMA‑targeted therapies, positioning Pluvicto at a strategic entry point ahead of forthcoming entrants.
- Regulatory Momentum – The NMPA’s priority review pathway typically shortens the post‑approval review cycle by 6–12 months; this may enable expedited access to other global indications (e.g., breast, lung, gastrointestinal).
- Strategic Partnerships – Novartis is exploring co‑distribution arrangements with local oncology networks to maximize market penetration and reimbursement coverage.
A clear signal that RLT, and Pluvicto in particular, are rapidly gaining traction within the evolving landscape of precision‑radiotherapy for prostate cancer.-Fineline Info & Tech