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Old 06-19-2009, 09:01 AM   #17
schoonder
Senior Member
 
Join Date: Jul 2008
Posts: 186
I don’t know if Dr. Rugo, a t-dm1 investigator at UCSF has made any progress with FDA petition for drug’s “compassionate use”. I do know that one of her conditions has been met, t-dm1 is presently being evaluated in a phase III setting. Here’s an excerpt from article in Cure magazine that quoted her intent:

“In terms of potential treatments for metastatic disease, “There is just a whole explosion of drugs out there,” Hope Rugo, MD, of the University of California at San Francisco, said in an interview with CURE.
One of those drugs is trastuzumab-DM1 (T-DM1). According to data from a phase II trial presented by Svetislava Vukelja, MD, of Tyler Cancer Center, T-DM1 has anti-tumor activity in patients with previously treated HER2-positive metastatic breast cancer, including activity in patients who have been pretreated with trastuzumab or lapatinib.
Rugo was one of the investigators in the trial, and she explained, in an interview with CURE, that T-DM1 is Herceptin linked to a chemotherapy drug that acts as a toxin. It works by taking advantage of the fact that the HER2 receptor binds to Herceptin and brings it into the cell. “So if the Herceptin has a toxin attached to it, you are delivering the toxic payload straight to the cancer cell. It’s called a smart-bomb approach.” Rugo said T-DM1 has been so effective in treating patients whose disease has progressed despite treatment, her team is looking into the possibility of petitioning the Food and Drug Administration to allow compassionate use of the drug after it enters phase III trials.
Rugo added that oncologists are exploring whether existing drugs could be used in new ways. “Maybe in the future, when we’re combining biologic agents, we can combine oral agents with an antibody. That’s very encouraging, because these are drugs that are already out there,” she concluded.”

And yes, life is much too precious to have it abridged by obvious shortcomings in expediency of how today’s new generation of drugs are made available to critically ill patients.
Possibly following link will help you on your journey to obtain this drug.
http://www.canceractionnow.org/living/cat_compassionate_use_and_expanded_access.php



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