Wednesday, April 18, 2012

Avastin fails again. Plain simply!

The theorem about inefficiency of Big Pharma in drug development was proven. From my point of view a par excellence example of such inefficiency was the development of Avastin. Avastin is a perfect drug for Big Pharma due to the following reasons:

1.       The development process was very costly and complicated (targeted biologicals) which "motivates" high cost of the medicine

2.       The manufacturing process is also not simple which again motivates high cost of the medicine

3.       Drug therapeutic efficiency is questionable and the use is driven very much by aggressive PR


But to be successful the drug has to show some efficacy! FDA earlier rejected Avastin for treatment of breast cancer. And guess what? Now a clinical trial showed that it is inefficient in lung cancer in elderly patients!



 “Patients in the Avastin group had a 39.6 percent probability of surviving one year, compared with 40.1 percent getting chemotherapy from 2006-2007 and 35.6 percent for those treated earlier than 2006, the study found. More recent data might yield different results, the researchers said.



Avastin, a $5.8 billion-a-year product also known as bevacizumab, won U.S. Food and Drug Administration approval for non-small cell lung cancer in 2006, after a study found the therapy improved survival by a median of two months. That research showed no benefit among patients aged 65 and older, who are covered by Medicare, the government health-insurance program for the elderly and disabled. At least two-thirds of patients with lung cancer qualify for Medicare, which has covered Avastin for that use since FDA approval, the authors said.



“Clinicians should exercise caution in making treatment recommendations and should use bevacizumab judiciously for their older patients,” the researchers wrote. About 22 percent of patients diagnosed with the disease in 2007 were given Avastin as part of their first-line chemotherapy, suggesting the product’s adoption “was by no means universal,” they said”



Well, I am waiting for new trials, new data analysis – I think that inefficiency of Avastin (and other MABs) will be clearly demonstrated under closer and more unbiased analysis.  

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