Tookad (padeliporfin)
- Region
- 🇪🇺 EU
- Active substance
- padeliporfin
- Company
- STEBA Biotech S.A
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 14 Sep 2017
- EU approval
- Fri 10 Nov 2017
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004182
- ATC
- L01XD07
- Official record
- www.ema.europa.eu
Indication
Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and: Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ? 50 % cancer involvement in any one core or a PSA density ? 0.15 ng/mL/cm³.
Regulatory milestones
No milestones recorded in the last year.
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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.