Pluvicto

RSS

lutetium (177Lu) vipivotide tetraxetan

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 02/02/2023

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 monitoringAdditional 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
1
Date of issue of marketing authorisation valid throughout the European Union
09/12/2022
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
D04 A9N6 
Ireland

Product information

30/01/2023 Pluvicto - EMEA/H/C/005483 - N/0001

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Product information documents contain:

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.

Assessment history

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