HER2 Support Group Forums - View Single Post - Genentech receives FDA Refuse to File Letter for T-DM1

Barbara H. · 08-27-2010, 05:04 PM

This decision is unbelievable. I started this drug in September, 2007. At the time I had enough pain in my hip from bone mets that I could not sleep more than two hours at night. I had just started teaching again and was desperate for this trial to open. It did, and my pain was completely gone two days after I had my first infusion. It worked for me for two years until I had to go off because of a rare side effect of lung inflammation. I am the only person I know who has had this side effect. I have been on Tykerb and Herceptin since this past October and it is also working. I am thrilled because both T-DM1 and Tykerb have been very easy drugs to tolerate. I basically feel as if I am not even being treated. I could go back on TDM-1 with cautious monitoring once it becomes available. I was hoping that it would be an option at the point that Tykerb begins to fail.

I feel really sad about this decision because I am convinced that there are many of us with HER-2 breast cancer who would greatly benefit from this drug, and at the same time lead an excellent quality life while being treated.

I wish the people who made this decision had spoken to the patients for whom this drug has been so life changing.

This has been a difficult year for many here, and devastating for us for losing Joe. My heart goes out for those of you that were hoping to use this drug soon.

Kind regards,
Barbara H.

08-27-2010, 05:04 PM	#13
Barbara H. Senior Member Join Date: Sep 2005 Location: Newton, MA Posts: 951	Re: Genentech receives FDA Refuse to File Letter for T-DM1 This decision is unbelievable. I started this drug in September, 2007. At the time I had enough pain in my hip from bone mets that I could not sleep more than two hours at night. I had just started teaching again and was desperate for this trial to open. It did, and my pain was completely gone two days after I had my first infusion. It worked for me for two years until I had to go off because of a rare side effect of lung inflammation. I am the only person I know who has had this side effect. I have been on Tykerb and Herceptin since this past October and it is also working. I am thrilled because both T-DM1 and Tykerb have been very easy drugs to tolerate. I basically feel as if I am not even being treated. I could go back on TDM-1 with cautious monitoring once it becomes available. I was hoping that it would be an option at the point that Tykerb begins to fail. I feel really sad about this decision because I am convinced that there are many of us with HER-2 breast cancer who would greatly benefit from this drug, and at the same time lead an excellent quality life while being treated. I wish the people who made this decision had spoken to the patients for whom this drug has been so life changing. This has been a difficult year for many here, and devastating for us for losing Joe. My heart goes out for those of you that were hoping to use this drug soon. Kind regards, Barbara H.