European Union - English - EMA (European Medicines Agency)

steba biotech s.a - padeliporfin di-potassium - prostatic neoplasms - antineoplastic agents - 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.