Steba Biotech Innovation

Our website is under construction because of marketing authorization

Marketing Authorization for TOOKAD® granted by European Commission
(http://ec.europa.eu/health/documents/community-register/html/h1228.htm#proc139127)



Steba Biotech announce that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) on 14 September 2017. The European Commission has granted Marketing Authorization for TOOKAD® (padeliporfin), used as part of a focal, Vascular-Targeted Photodynamic therapy (VTP), on 10 November 2017.

TOOKAD® is approved for use in the 28 countries of the European Union (EU) and European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway).

The regulatory filing for TOOKAD® is supported by two years of data from its phase III, active-controlled, randomized study in which TOOKAD® met its two primary objectives.

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.

TOOKAD® focal therapy is a new therapeutic option that reduces the overall toxicity such as erectile dysfunction and urinary incontinence in comparison with active surveillance and radical therapy.

For more information, please contact info@stebabiotech.com.