Johnson & Johnson (NYSE: JNJ) may have an even larger winner with its prostate cancer drug called ZYTIGA. The Food & Drug Administration has approved an expanded indication in men for the treatment of metastatic castration-resistant prostate cancer. Before today’s news, ZYTIGA has only been approved for use by those men who have received prior chemotherapy containing docetaxel. Now the FDA is allowing ZYTIGA and prednisone to be used earlier in the treatment continuum for metastatic castration-resistant disease, before the use of chemotherapy.
The news is coming out of the Janssen unit and the company went on to say, “ZYTIGA also received a positive opinion for an expanded indication from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is under review by other health authorities worldwide.”
ZYTIGA in combination with prednisone was approved by the FDA in April 2011 for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel. Since its first US approval, ZYTIGA has been approved in more than 65 countries and over 40,000 men worldwide have received treatment with it. Janssen claims that it is quickly becoming one of the cornerstones of treatments.
The news could be just one more bit of bad news for Dendreon Corporation (NASDAQ: DNDN) as PROVENGE continues to struggle to become a more widely used treatment against metastatic prostate cancer. Even if Dendreon shares are up by close to 4% on Monday, the $5.05 stock is way down from its prior peak and its 52-week range is $3.69 to $17.04.
JON C. OGG