Overview
Lutetium Lu-177 vipivotide tetraxetan is a radioligand therapeutic agent. It consists of a radionuclide, lutetium Lu-177, linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer. Lutetium Lu-177 vipivotide tetraxetan was first approved by the FDA on March 23, 2022 as a treatment for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended lutetium Lu-177 vipivotide tetraxetan be granted marketing authorization for the treatment of prostate cancer. In December 2022, lutetium Lu-177 vipivotide tetraxetan was approved by the EMA.
Indication
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
Associated Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/02 | Not Applicable | Not yet recruiting | |||
2025/08/28 | Not Applicable | Not yet recruiting | |||
2025/07/02 | Not Applicable | Recruiting | |||
2025/06/17 | Phase 2 | Not yet recruiting | |||
2025/05/11 | Phase 2 | Not yet recruiting | |||
2025/04/24 | Phase 1 | Recruiting | Jean-Mathieu Beauregard | ||
2025/03/25 | Phase 2 | Recruiting | |||
2025/01/20 | Phase 2 | Not yet recruiting | |||
2024/10/09 | Phase 2 | Recruiting | |||
2024/08/01 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Accelerator Applications USA, Inc | 69488-010 | INTRAVENOUS | 27 mCi in 1 mL | 10/19/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/9/2022 | ||
Authorised | 12/9/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PLUVICTO SOLUTION FOR INJECTION/INFUSION 1000 MBq/mL | SIN16917P | INJECTION, SOLUTION (RADIOPHARMACEUTICAL) | 1000 MBq/mL | 12/18/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PLUVICTO lutetium (177Lu) vipivotide tetraxetan 1000 MBq/mL solution for injection vial | 410282 | Medicine | A | 7/17/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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