【FDA Approval Alert】Novartis’s Pluvicto Indication Expanded for PSMA-Positive mCRPC (March 28, 2025)
On March 28, 2025, the U.S. FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to include adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are appropriate to delay taxane-based chemotherapy. The approval is based on PSMAfore trial (NCT04689828).
Disease Overview: Indication Expansion in mCRPC
PSMA-positive mCRPC represents advanced treatment-resistant prostate cancer. Pluvicto offers an option to delay taxane initiation after ARPI therapy. PSMA PET imaging is required for patient selection.
Treatment Summary
- Drug Name: lutetium Lu 177 vipivotide tetraxetan (Pluvicto)
- Company: Novartis Pharmaceuticals Corporation
- Approval Date: March 28, 2025
- Indication: PSMA-positive mCRPC post-ARPI, pre-taxane setting
- Mechanism of Action: Radioligand therapy (RLT)
- Pivotal Trial: PSMAfore (NCT04689828)
- Key Efficacy:
- Median rPFS: 9.3 vs 5.6 months (HR 0.41; p<0.0001)
- Median OS: 24.5 vs 23.1 months (not statistically significant)
Patient-Friendly Summary
Pluvicto delivers targeted radiation to prostate cancer cells, providing a new option to postpone chemotherapy in patients with PSMA-positive mCRPC.
M&A Information
- Subsidiary: Not applicable (Novartis in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (SWX: NOVN)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
