HER2 Support Group Forums - View Single Post - GSK withdraws tykerb+herceptin application from FDA

Nancy L · 07-13-2012, 04:58 PM

I was on the t/h combo from 2/2009 to 6/2012 when it was confirmed that I have a 2 1/2 cm tumor in my right supraclavical area. Based on the size or the tumor and how I have been feeling, I think T/H stopped working over a year ago but they just couldn't confirm anything on scans. I am currently going trough radiation therapy and looking for a drug trial of TDM-1. I had hoped to get Perjeta + Herceptin which is what Dr. Slamon ordered for me but it looks like Genentech is not going to give it to me. And it can't be about the cost of producing a dose of Perjeta---the research costs have been incurred over many previous years and are sunk costs unless they can get more women approved for this protocol. Dr. Slamon told me he was working with Perjeta in his lab at the same time as they were studying Herceptin. They went with Herceptin because it was slightly better. But he said the two drugs given together work better than either of them work as a single agent. And even he doesn't have the pull and respect which would allow him to prescribe what he thinks is best for my individual situation.

My feeling is that any woman who is Stage IV should be able to sign a liability release and get access to any of these combos that have shown success, even if it is only been for one woman. The researchers could learn a lot quickly if they allowed more woman in the tent than blocking the door. It almost makes you believe the FDA really isn't interested in personalized medicine and want to continue approving the "one size fits all" treatment programs for metatasis which we all know do not work. If a drug is basically safe to administer to humans, I think they should be out of the business of deciding if it works for a large group of women. The FDA should strickly be about determining safety and let the women with the disease demononstrate if the drugs work or not. Even on the safety issue I guestion the FDA objective---which is more cruel???? 1) letting a woman die of the disease 2) letting a woman die from taking a drug that might stop the disease and learning something for others. The time wasted fighting for HER2 drugs is cruel to the patients and their families. I was so sure I could have another targeted therapy to try when T/H stopped working but now I am not so sure.

07-13-2012, 04:58 PM	#9
Nancy L Senior Member Join Date: Apr 2009 Location: La Quinta, Ca Posts: 253	Re: GSK withdraws tykerb+herceptin application from FDA I was on the t/h combo from 2/2009 to 6/2012 when it was confirmed that I have a 2 1/2 cm tumor in my right supraclavical area. Based on the size or the tumor and how I have been feeling, I think T/H stopped working over a year ago but they just couldn't confirm anything on scans. I am currently going trough radiation therapy and looking for a drug trial of TDM-1. I had hoped to get Perjeta + Herceptin which is what Dr. Slamon ordered for me but it looks like Genentech is not going to give it to me. And it can't be about the cost of producing a dose of Perjeta---the research costs have been incurred over many previous years and are sunk costs unless they can get more women approved for this protocol. Dr. Slamon told me he was working with Perjeta in his lab at the same time as they were studying Herceptin. They went with Herceptin because it was slightly better. But he said the two drugs given together work better than either of them work as a single agent. And even he doesn't have the pull and respect which would allow him to prescribe what he thinks is best for my individual situation. My feeling is that any woman who is Stage IV should be able to sign a liability release and get access to any of these combos that have shown success, even if it is only been for one woman. The researchers could learn a lot quickly if they allowed more woman in the tent than blocking the door. It almost makes you believe the FDA really isn't interested in personalized medicine and want to continue approving the "one size fits all" treatment programs for metatasis which we all know do not work. If a drug is basically safe to administer to humans, I think they should be out of the business of deciding if it works for a large group of women. The FDA should strickly be about determining safety and let the women with the disease demononstrate if the drugs work or not. Even on the safety issue I guestion the FDA objective---which is more cruel???? 1) letting a woman die of the disease 2) letting a woman die from taking a drug that might stop the disease and learning something for others. The time wasted fighting for HER2 drugs is cruel to the patients and their families. I was so sure I could have another targeted therapy to try when T/H stopped working but now I am not so sure.