The UK’s Medicines and Healthcare Products Regulatory Agency has expanded the licence for Wyeth Pharmaceutical’s Prostap, effectively granting a larger subset of patients with prostate cancer access to the drug.
Prostap was first approved by European regulators in 2004 for ad
vanced stage prostate cancer, and works by reducing the production of leuteinising hormone, thereby lowering the levels of testosterone, which most prostate cancers depend on for growth.
Now, following a review of current clinical evidence and practice, the regulator has updated treatment gu
idelines so that Prostap SR (leuprorelin acetate 3.75mg) and Prostap 3 (11.25mg) can be used in: metastatic prostate cancer; locally-advanced prostate cancer as an alternative to surgical castration; as an adjuvant to radiotherapy in patients with high-risk localised or locally-advanced forms of the disease; and as an adjuvant to radical prostatectomy in patients with locally-advanced disease at a high risk of progression.
With around 32,000 cases diagnosed in the country every year, “prostate cancer is the most common cancer in the UK among men, [and] these new indications mean doctors will now have important additional treatment options for men at all stages of the disease,” commented Professor Stephen Langley from the Prostate Cancer Centre in Guildford.
The National Health Service list price of the three-monthly therapy Prostap 3 is £376.20 per injection, while that for the monthly version Prostap SR is £125.40, a company spokesperson told PharmaTimes UK News.
