HER2 Support Group Forums - View Single Post - FDA Raises Questions About Benefits Of Avastin For Breast Cancer Patients

gdpawel · 12-08-2010, 06:56 PM

The UK’s National Institute for Health and Clinical Excellence has rejected the use of Roche’s Avastin for treating breast cancer on the grounds that the med offers “limited and uncertain benefit” for patients compared with existing treatments. Roche had calcuated the total average cost of treating a patient with Avastin plus chemotherapy is more than $52,000.

“Unfortunately, we did not receive any evidence from the manufacturer to show that (Avastin) can significantly lengthen a patient’s life or, importantly, offer a better quality of life than existing treatments. Although the data seemed to show that the drug may slow the growth and spread of the cancer, the size of this effect varied between studies. Furthermore, it was extremely unclear that the benefits in terms of slowing tumour growth translated into benefits on overall survival, which is what really matters for patients,” NICE chief executive Andrew Dillon says in a statement.

Nonetheless, the decision casts an ominous shadow over an upcoming decision by the FDA. Last July, you may recall, an FDA advisory committee dealt Roche a blow by voting 12 to 1 to recommend the agency withdraw approval for the multibillion-dollar cancer drug for treating breast cancer. The FDA approved Avastin two years ago to fight breast cancer, but two studies - which were undertaken as a condition of approval - found patients given Avastin and chemotherpay didn’t survive longer than those given chemo alone. Avastin patients also suffered more serious side effects.

The Avastin decision has stirred controversy over the yardsticks used to approve Avastin for breast cancer treatment and the FDA’s accelerated approval program. For instance, one advocacy group, Breast Cancer Action, maintains the FDA placed too much emphasis on surrogate markers, specifically, progression-free survival. Meanwhile, some cancer patients worry the agency will yank the med, which in some cases has been proven helfpul.

Source: Pharmalot

http://www.nice.org.uk/newsroom/pres...eastCancer.jsp

http://www.pharmalot.com/2010/07/fda...breast-cancer/

12-08-2010, 06:56 PM	#7
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	NICE: patient benefits of Avastin are too small to justify its very high cost The UK’s National Institute for Health and Clinical Excellence has rejected the use of Roche’s Avastin for treating breast cancer on the grounds that the med offers “limited and uncertain benefit” for patients compared with existing treatments. Roche had calcuated the total average cost of treating a patient with Avastin plus chemotherapy is more than $52,000. “Unfortunately, we did not receive any evidence from the manufacturer to show that (Avastin) can significantly lengthen a patient’s life or, importantly, offer a better quality of life than existing treatments. Although the data seemed to show that the drug may slow the growth and spread of the cancer, the size of this effect varied between studies. Furthermore, it was extremely unclear that the benefits in terms of slowing tumour growth translated into benefits on overall survival, which is what really matters for patients,” NICE chief executive Andrew Dillon says in a statement. Nonetheless, the decision casts an ominous shadow over an upcoming decision by the FDA. Last July, you may recall, an FDA advisory committee dealt Roche a blow by voting 12 to 1 to recommend the agency withdraw approval for the multibillion-dollar cancer drug for treating breast cancer. The FDA approved Avastin two years ago to fight breast cancer, but two studies - which were undertaken as a condition of approval - found patients given Avastin and chemotherpay didn’t survive longer than those given chemo alone. Avastin patients also suffered more serious side effects. The Avastin decision has stirred controversy over the yardsticks used to approve Avastin for breast cancer treatment and the FDA’s accelerated approval program. For instance, one advocacy group, Breast Cancer Action, maintains the FDA placed too much emphasis on surrogate markers, specifically, progression-free survival. Meanwhile, some cancer patients worry the agency will yank the med, which in some cases has been proven helfpul. Source: Pharmalot http://www.nice.org.uk/newsroom/pres...eastCancer.jsp http://www.pharmalot.com/2010/07/fda...breast-cancer/