The FDA approved a new cancer stalling drug, Avastin, for women with advanced breast cancer and those in need of lung and colon cancer treatment.
An expert panel of advisors to the FDA voted against the drug because the drug's ability to slow the growth of cancerous tumors did not outweigh the risk of blood clots and other cardiovascular problems leading to a rare number of deaths and a significant number of patients who experienced no gain from experiments during testing.
"Avastin improves progression-free survival, but we don't know if it improves overall survival," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "There are increased side effects [and] risks in using Avastin, but, in appropriate patients, it may be beneficial."
In trial results submitted to the FDA by Genentech before the advisory panel met, the use of Avastin (bevacizumab) did stall malignancy in women with advanced breast cancer by an average of 5.5 months, when combined with paclitaxel, but the same study of 722 patients showed that patients reaped no gain in overall survival after taking Avastin.
Avastin, with a price tag of $50,000 per year, is currently being tested against 20 cancers in 300 trials and this latest approval is expected to add more than $700 million in annual sales to the $2.3 billion in sales that was generated in 2007 by the drug's use among lung and colon cancer patients.
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