Janssen-Cilag International announced that, after a regulatory review process accelerated by the European Medicines Agency (EMA) and following a positive opinion of the Committee for Medicinal Products for Human Use (CHMP) on July 22 2011, the European Commission has approved the authorization to market the drug Zytiga (Abiraterone acetate), a novel inhibitor of androgen biosynthesis, for oral administration in a single daily dose. Abiraterone acetate is approved in combination with prednisone or prednisolone for the treatment of prostate cancer metastatic castration-resistant (mCRPC) in adult males in which the disease has progressed during or after a chemotherapy regimen based on docetaxel.

“The approval by the European Commission Abiraterone acetate offers new hope to patients suffering from prostate cancer at this late stage, for which few treatment options remain,” said Professor Karim Fizazi, Department of Oncology, Institut Gustave Roussy, France, who has participated as an investigator to the fundamental study of phase III of Abiraterone acetate. “The efficacy, safety and ease of use of Abiraterone acetate, a drug that can be taken at home, will answer to an important unmet medical needs for many patients, helping them to live longer, with better quality of life and less pain.”

Abiraterone acetate is an inhibitor that inhibits the complex biosynthetic enzyme CYP17 necessary for the production of androgens. androgen hormones (eg. testosterone) are hormones that promote the development and maintenance of male sexual characteristics. However, in prostate cancer , androgens may stimulate cancer growth androgen hormones are produced primarily in the testes and adrenal glands, but in men with prostate cancer, the tumor tissue is another source of androgens. Abiraterone The acetate is the first oral drug for metastatic prostate cancer resistant to castration, androgen, which inhibits the production of all three sources.

The results of the landmark study of phase III, multi-centre, randomized, placebo-controlled have shown that pre-specified interim analysis, after a follow-up of 12.8 months, Abiraterone acetate therapy in combination with prednisone or prednisolone produced a 35.4% reduction in risk of death [hazard ratio (HR) = 0.65, 95% CI: 0.54, 0.77, P <0.001]) and an improvement of 3.9 months the average overall survival (14.8 months versus 10.9 months) compared to placebo plus prednisone or prednisolone. In an updated analysis (with a median follow-up of 20.2 months), the results were consistent with those of the analysis with a temporary improvement in overall survival of 4.6 months of average between the two arms (15.8 months versus 11.2 months [HR = 0.74]) for dell'abiraterone acetate. The effect of Abiraterone acetate and prednisone on the overall survival was consistent across all subgroups.

In patients who reported to suffer significant pain as a result of their illness (a pain score of 4 or more baseline using the Brief Pain Inventory Scale-Short Form [BPI-SF] 0 to 10) and with at least a score of pain post-baseline, the percentage who reported onset of pain relief (a reduction of at least 30% compared to baseline score maximum BPI-SF pain intensity within 24 hours without any increase in the use of analgesics, observed score in two consecutive evaluations at a distance of four weeks apart) was higher in the group treated with Abiraterone acetate compared with placebo group (44% vs. 27%, p = 0.002).

A smaller proportion of patients treated with acetate Abiraterone reported events related to the skeletal system, compared with patients receiving placebo (18% vs. 28% at six months, 30% versus 40% at 12 months and 35% versus 40% at 18 months ). For event related to the skeletal system is meant a pathologic fracture (a fracture caused by a weakening disease USS), the compression of the spinal cord, palliative irradiation of bone tissue (used to reduce bone pain) or bone surgery.

“In patients who have exhausted standard therapeutic options, including chemotherapy, offers a new option Abiraterone acetate, well-tolerated for the treatment of this devastating disease,” explained Professor Johann S de Bono, MD, FRCP, MSc, PhD, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, one of the principal investigators of the clinical trial phase III. “In Europe, prostate cancer is the third most common cause of cancer death and is therefore essential to be developed as new treatment options Abiraterone acetate.”

Overall, adherence to treatment with Abiraterone acetate was high and side effects were manageable and reversible, despite his advanced age and the level of fragility of the study population. The most common adverse reactions observed with Abiraterone acetate has been peripheral edema, hypokalemia, hypertension and urinary tract infections.

Abiraterone acetate should be taken once daily on an empty stomach, at least two hours before meals and food should not be consumed for at least an hour after the assuzione tablets.

Abiraterone acetate and prednisone was evaluated in a multi-centre clinical trial, placebo-controlled, randomized, phase III of patients who had previously received docetaxel-containing chemotherapy (N = 1.195). Patients were randomized in a 2:1 ratio to receive Abiraterone acetate in a dose of 1,000 milligrams (mg) per day plus 5 mg of prednisone or prednisolone or placebo twice daily in combination with prednisone or prednisolone 5 mg twice per day (control arm). This randomized, double-blind, placebo-controlled, phase III was conducted in 147 centres in 13 countries.

Prostate cancer metastatic castration resistant, abbreviated mCRPC, occurs when a cancer has metastasized (spread) beyond the prostate and the disease progresses despite the fact that both serum testosterone levels below the castration.

The prostate is a gland that in humans, produces the seminal fluid and is located around the urethra (below the bladder). [6]In some cases, prostate cancer can grow slowly compared to other cancers. However, depending on factors including the specific characteristics of the patient and the tumour, prostate cancer can develop very rapidly and spread widely.

It is estimated that in 2008 there were 370,000 new cases diagnosed in Europe of prostate cancer and almost 90,000 men died from the disease.

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