The National Institute for Health and Care Excellence has concluded that Steba Biotech’s Tookad is not cost-effective enough to be approved enough for NHS funding to treat prostate cancer.

In preliminary guidelines, the Institute’s appraisal committee said the drug is not cost effective for untreated unilateral, low-risk prostate cancer in adults when compared with active monitoring, surgery or radiotherapy.

“Clinical trial evidence shows padeliporfin can slow disease progression, but its long-term effectiveness is unclear and there is no evidence to show how effective it is when compared with surgery or radiotherapy,” NICE said.

Tookad (padeliporfin) is a light-sensitive drug that is administered intravenously. Light via optical fibres inserted into the prostate activates the drug, which kills the cancer cells.

Earlier this year, the Journal of Urology published four-year follow up data of the landmark PCM301 trial, showing that vascular targeted photodynamic therapy (VTP) mediated by Tookad significantly reduced the subsequent finding of higher-grade cancer on biopsy, and, consequently, significantly fewer patients converted to radical therapy (RT), typically surgery or radiotherapy.

The rate of conversion to RT after Tookad VTP compared with active surveillance at two years (7 percent vs 32 percent) was maintained at three (15 percent vs 44 percent) and four years (24 percent vs 53 percent).

The reduction in conversion to RT is a clinically-meaningful outcome, as it lowers treatment-related morbidity, the firm noted.