The UK National Institute for Health and Clinical Excellence (NICE) has recommended Ferring Pharmaceuticals’ Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate cancer.
The drug has been recommended specifically for patients with spinal metastases who show signs or symptoms of impending spinal cord compression (ISCC).
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Compared with existing hormonal therapies, Firmagon has shown several advantages that include more rapid reduction in prostate specific antigen (PSA), better control of Serum Alkaline Phosphatase (S-ALP), which denotes tumour activity in the bones, and significant reduction in PSA progression.
Firmagon, administered as a deep subcutaneous injection, is claimed to rapidly reduce levels of testosterone by blocking the gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland.
The drug works by suppressing luteinising hormone and follicle-stimulating hormone, and thereby decreasing production of testosterone, which is necessary for prostate cancer growth, by the testicles.
Northampton General Hospital consultant cardiologist Patrick Davey said that given the high UK prevalence of prostate cancer and also cardiovascular disease (CVD), it means that an estimated one in three men with prostate cancer would have experienced a cardiovascular event.
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By GlobalData"Patients with pre-existing CVD are most at risk and the evidence shows that Firmagon has a higher chance of reducing that," Davey said. "It is unfortunate that NICE has chosen not to recommend it in a wider patient group."
In addition, fewer musculoskeletal events and a lower incidence of renal or urinary tract events, compared with men treated with LHRH agonists, have been showed in clinical studies.
In these trials, the drug has shown significantly longer progression-free survival and a more rapid response compared with agonist treatment.
Whipps Cross University Hospital Consultant Urological Surgeon professor James Green said: "NICE’s decision is frustrating as I would like to be able to give more of my prostate cancer patients the hope of positive outcomes from degarelix treatment."
Ferring UK general manager Steven Howson added: "Whilst we are pleased that NICE has recommended Firmagon for certain prostate cancer patients, it is obviously disappointing for the English and Welsh prostate cancer community and their physicians that full access has not been granted in all the patient groups where proven efficacy and safety benefits have been demonstrated over existing therapies. We now need to consider what our response to this will be".
In 2009, Firmagon was approved for treatment of advanced hormone-dependent prostate cancer in both the EU and US.
At present, the drug is available in around 40 countries worldwide, including a growing number in Asia, Latin America and the Middle East.
Image: Micrograph of prostate adenocarcinoma, acinar type, the most common type of prostate cancer. Photo: courtesy of Nephron.
