Pluvicto
lutetium (177Lu) vipivotide tetraxetan
Table of contents
Overview
Pluvicto is a medicine used to treat cancer of the prostate (a gland of the male reproductive system). It is used when the cancer is metastatic (spreading to other parts of the body), progressive, castration-resistant (worsens despite treatment to lower levels of the male sex hormone testosterone), and the cancer cells have a protein called prostate-specific membrane antigen (PSMA) on their surface (PSMA-positive prostate cancer).
Pluvicto is used together with androgen deprivation therapy (treatment to lower male sex hormones) in adults previously treated with androgen receptor pathway inhibitors (medicines for prostate cancer), and a medicine of the group of cancer medicines known as taxanes. Androgen receptor pathway inhibitors may also be added to Pluvicto and androgen deprivation therapy.
Pluvicto is a radiopharmaceutical (a medicine that gives off a small amount of radioactivity) that contains the active substance lutetium (177Lu) vipivotide tetraxetan.
-
List item
Pluvicto : EPAR - Medicine overview (PDF/123.97 KB)
First published: 21/12/2022
EMA/837969/2022 -
-
List item
Pluvicto : EPAR - Risk-management-plan (PDF/1.3 MB)
First published: 21/12/2022
Authorisation details
Product details | |
---|---|
Name |
Pluvicto
|
Agency product number |
EMEA/H/C/005483
|
Active substance |
lutetium (177Lu) vipivotide tetraxetan
|
International non-proprietary name (INN) or common name |
lutetium (177Lu) vipivotide tetraxetan
|
Therapeutic area (MeSH) |
Prostatic Neoplasms, Castration-Resistant
|
Anatomical therapeutic chemical (ATC) code |
V10XX
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
09/12/2022
|
Contact address |
Vista Building |
Product information
19/04/2023 Pluvicto - EMEA/H/C/005483 - IB/0004/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic radiopharmaceuticals
Therapeutic indication
Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.