CHMP recommends approval of Tookad (padeliporfin) for adenocarcinoma of the prostate.- STEBA Biotech.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tookad (padeliporfin), from STEBA Biotech, intended for the treatment of adult patients with adenocarcinoma of the prostate. Tookad is administered as part of focal vascular-targeted photodynamic therapy (VTP). Tookad will be available as a powder (183 mg and 366 mg) for solution for injection.

The active substance of Tookad is padeliporfin, a sensitiser used in photodynamic/radiation therapy. When activated with laser light, padeliporfin triggers a cascade of pathophysiological events resulting in focal necrosis within a few days. 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.