Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
- Region
- 🇪🇺 EU
- Active substance
- lutetium (177Lu) vipivotide tetraxetan
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms, Castration-Resistant
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Fri 09 Dec 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005483
- ATC
- V10XX
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Follow Pluvicto
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.