2 Information about padeliporfin

2 Information about padeliporfin

Marketing authorisation indication

Padeliporfin (Tookad, Steba Biotech) is indicated as monotherapy for 'adults 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 no more than 6, based on high-resolution biopsy strategies

  • prostate-specific antigen (PSA) no more than 10 ng/ml

  • 3 positive cancer cores with a maximum cancer core length of 5 mm in any 1 core or 1 to 2 positive cancer cores with at least 50% cancer involvement in any 1 core or a PSA density of at least 0.15 ng/ml/cm3'.

Dosage in the marketing authorisation

The recommended dose, given intravenously is a single dose of 3.66 mg/kg of padeliporfin, given using a vascular-targeted photodynamic therapy procedure.

Price

The list price of padeliporfin is £3,761 per 183 mg vial (excluding VAT; company submission). The average cost of treatment is £12,111 per patient (including consumables and leasing the laser; excluding VAT; company submission). The company has a commercial arrangement, which would apply if the technology had been recommended.

  • National Institute for Health and Care Excellence (NICE)