The breast cancer drug Avastin, while it showed promise after an accelerated approval by the FDA back in 2008 due to promising cancer halting results when paired with a chemotherapy drug (unfortunately – you can tell, I’m not too sure personally about chemotherapy, it almost does more harm than good sometimes), has actually just gone back to the drawing table in terms of approval.
The FDA pushed it through because it had shown that when paired with one particular chemotherapy drug for breast cancer, it halted the progression of the breast cancer for 5 months, which is pretty significant especially in cases where the cancer was very agressive.
Breast cancer can progress very quickly when it is in certain stages, and for a drug, or a combination of drugs, to halt it for that period of time can be pretty significant in terms of life extension. The question, of course, is what kind of quality of life does the patient have in those five months, or leading up to, and would it really be worth any potential side effects?
Well now, the drug Avastin’s approval has been delayed due to other preliminary studies that show that the drug does not work as well when paired with other chemotherapy drugs. It only halted the breast cancer’s progression by about one to two months with the other chemo drugs, and that is a concern for the FDA, who usually has higher standards for approval of these types of serious drugs when it involves life extending benefits.
The extended review will be for 90 days, and in mid December of 2010, they will supposedly make a final decision on whether the drug, which is made by drug company Roche, will make the cut or not. I bet the investors in Roche and the management is definitely waiting with baited breath on this one since of course the company stands to have a blockbusting drug on their hands if it proves to be effective.
The FDA is really considering whether to revoke the drug’s approval though after the disappointing second round of results with the other chemo drugs as a complementary therapy, so it will be interesting to see what they pull out of their hat, or why they’re waiting to approve it or disapprove it. I mean, do they have more studies, or are they just still going to debate the ones that they’ve already seen? This FDA stuff can be confusing…
