Reuters Health Information (2007-09-21): EU agency backs Bayer's Nexavar for liver cancer
EU agency backs Bayer's Nexavar for liver cancer
Last Updated: 2007-09-21 12:34:49 -0400 (Reuters Health)
LONDON (Reuters) - The European Medicines Agency has recommended approval of Bayer and Onyx Pharmaceuticals' oral medication Nexavar (sorafenib) as a treatment for liver cancer, the agency said on Friday.
The drug is already approved in Europe and the United States for kidney cancer.
It became the first medication to extend the life of patients with advanced liver cancer in a large study -- adding about 3 months to survival compared with a placebo -- according to trial results released in June.
Recommendations for marketing approval by the European agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
Nexavar is also being tested against several other types of cancer, including non-small cell lung cancer and breast cancer.
The drug is being reviewed as a treatment for liver cancer in the United States.