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Date: 2017-11-10

Type of information: Granting of a Market Authorisation in the EU

Product name: Tookad®

Compound: padeliporfin di-potassium

Therapeutic area: Cancer - Oncology

Action mechanism:

  • photosensitizer/photodynamic therapy. Tookad® is a first-in-class photosensitizer derived from palladium-substituted bacteriochlorophyll and developed in collaboration with the Weizmann Institute. It was designed to address limitations of previous attempts in photodynamic therapies. When activated with laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days.
  • Steba Biotech, a privately-owned, biotechnology company headquartered in Luxembourg with offices in France, Israel, Switzerland, and the US, is also pursuing early stage studies of Tookad® in esophageal cancer, urothelial carcinoma, advanced prostate cancer, renal carcinoma, and triple negative breast cancer in collaboration with Memorial Sloan Kettering Cancer Center, the Weizmann Institute, and Oxford University.

Company: Steba Biotech (Luxembourg)

Disease: previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy  of at least 10 years

Latest news:

  • • On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Tookad® (padeliporfin), intended for the treatment of adult patients with adenocarcinoma of the prostate. Tookad is administered as part of focal vascular-targeted photodynamic therapy.  It will be available as a powder (183 mg and 366 mg) for solution for injection.
  • The benefits with Tookad® are its ability to improve the probability of a negative biopsy at 24 months and delay disease progression compared with active surveillance (periodic monitoring of known prostate cancer). The most common side effects are urinary and reproductive system disorders.
  • The full indication is: “Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy of at least 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.
  • ” It is proposed that Tookad® be restricted to hospital use only. It should only be used by personnel trained in the vascular-targeted photodynamic therapy procedure.
  • • On January 25, 2016, Steba Biotech announced that the company has submitted on January 7, 2016 a Marketing Authorization Application to the European Medicine Agency (EMA) for Tookad®. The MAA requests EMA approval of Tookad® for the treatment of localized prostate cancer.
 

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE: 2016-01-07

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2017-11-10

Favourable opinion UE: 2017-09-14

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes