Basic Information
Pluvicto
Regulatory Information
EMEA/H/C/005483
December 9, 2022
October 13, 2022
10
March 27, 2025
Company Information
Ireland
Vista Building Elm Park Merrion Road Dublin 4 D04 A9N6
NOVARTIS EUROPHARM LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.