FDA Permits Using Johnson & Johnson Cancer Drug Without Chemo
On Monday, Johnson & Johnson subsidiary Janssen Research & Development confirmed that the FDA has approved its oral, once-daily medication Zytiga for treatment of metastatic castration-resistant prostate cancer (mCRPC). Before this approval of more expansive usage, Zytiga had been approved for use only on patients who hadn't responded to prior chemotherapy containing docetaxel. As a result, the new "indication" permits doctors to prescribe Zytiga without first recommending chemo.
Additionally, Janssen noted that it has received a "positive opinion" for expanded usage of the drug from the European Medicines Agency's Committee for Medicinal Products for Human Use. Further approvals in other countries are also being sought.
"Excluding skin cancer, prostate cancer is the most frequently diagnosed cancer in men in the U.S.," Janssen noted in a press release. "In 2012, the American Cancer Society estimates more than 28,000 men will die from the disease, making it the second leading cause of cancer death behind lung cancer. There are approximately 35,000 new cases of mCRPC each year."
Shares of Johnson & Johnson closed up 0.2% on the news.
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