EU approval for Janssen-Cilag's Zytiga in prostate cancer and Novartis' Votubia for SEGA

Belgium-based Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), says that, after an accelerated regulatory review process by the European Medicines Agency and following a positive CHMP opinion (The Pharma Letter July 23), the European Commission has approved the marketing authorization for Zytiga (abiraterone acetate), a novel, once-daily, oral, androgen biosynthesis inhibitor.

Abiraterone acetate is approved, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.1

"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," said Karim Fizazi, professor at the Department of Cancer Medicine, Institut Gustave Roussy, France, who was an investigator in the abiraterone acetate pivotal Phase III study, and is quoted by the drugmaker. "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," he added.