US FDA approves J&J's Zytiga for late-stage prostate cancer and Spectrum's Fusilev for metastatic colorectal cancer

3 May 2011

Ahead of the holiday weekend, the US Food and Drug Administration announced a couple of new drug approvals: health care major Johnson & Johnson’s (NYSE: JNJ) Zytiga (abiraterone acetate) in combination with prednisone to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy), and fellow USA-based biotech firm Spectrum Pharmaceuticals’ (NasdaqGS: SPPI), Fusilev (levoleucovorin) in combination with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

Zytiga was developed by Cougar Biotechnology, a company that J&J acquired in July 2009 for $893.7 million, and which became part of the group’s Centocor Ortho Biotech unit, which will be responsible for marketing the drug.

Wells Fargo analyst Larry Biegelsen, quoted by MotelyFol, predicts $800 million in sales by 2015, and Mr Biegelsen expects a wholesale price of $5,000 per month, with typical treatments lasting eight months. Analaysts are forecsting peak annual sales for Zytigia of $800 to more than $1 billion.

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