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