European regulators approve J&J’s prostate cancer drug

Johnson & Johnson announced that the company’s investigational drug Zytiga (abiraterone acetate) has been approved by the European regulators. Zytiga is intended for the treatment of men with advanced prostate cancer in whom chemotherapy has already been conducted.

Professor Johann S. de Bono, MD, FRCP, MSc, PhD, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, and one of the co-lead researchers for the Phase 3 clinical investigation, said: “In patients who have exhausted standard treatment options, including chemotherapy, abiraterone acetate offers a novel, well tolerated option for treating this devastating disease. In Europe, prostate cancer is the third most common cause of cancer deaths so it is essential that new treatments options like abiraterone acetate are developed.”

The once-daily pill has been approved by the European Commission to be administered in combination with steroid prednisone.

Zytiga received US FDA approval in April. The drug acts by targeting a protein involved in testosterone synthesis, thereby reducing the levels of the hormone produced that could promote tumor growth.

Professor Karim Fizazi, Department of Cancer Medicine, Institut Gustave Roussy, France, who was a researcher in the abiraterone acetate pivotal Phase 3 investigation, explained:  “The European Commission approval of abiraterone acetate gives new hope to men who are suffering from this late stage of prostate cancer with very few treatment options left. The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain.”

According to J&J, treatment with a combination of Zytiga and prednisone was found to prolong life span by 4 months in contrast to treatment with a combination of prednisone and a placebo in a prostate cancer trial comprising 1,200 patients.

Cougar Biotechnology Inc., the developer of Zytiga, was bought over in July 2009 by the New Brunswick, N.J.-based giant drugmaker in a deal amounting to $893.7 million. Cougar amalgamated into Johnson & Johnson’s Centocor Ortho Biotech unit.

In Wednesday morning trading, J&J shares hiked 35 cents to $64.99, while the Dow Jones industrial average was up about 1.6 percent.