A physician's comment re T-DM1 RTF
"Wow, said a physician who was hearing the news. She developed HER2 breast cancer herself and tested positive for BRCA, which means she has inherited the breast cancer gene. As a matter of fact, her 28 year-old daughter tested also positive for the gene. She has not developed metastasis or any other tumor recurrence, but she is concerned. Commenting on the FDA letter explanation to its decision, the physician/patient said, “trying to figure out what the FDA meant by exhausting all available treatment choices approved for metastatic breast cancer, the question that keeps crossing my mind is: Haven’t those patients received prior Herceptin (trastuzumab), capecitabine, anthracycline, taxane and lapatinib. How much more drugs must they receive? You know what? The drugs would be exhausted when Genentech uses them all, but definitely the patients who would receive them will.” We asked the doctor/patient whether there are existing data on these drugs that were not used in T-DM1 trials, her answer was, “Of course the data exist and have been published, yet, why do we need them? Oncologists know that most non-specific treatments have not helped most HER2 breast cancer even in its early stages, let alone their recurrences. I wonder why should we withdraw the big hope that HER2 metastatic patients hung on since they heard about TDM-1 results – hope that has tremendously increased since these patients learned about the filing for early approval of the promising drug. Most these patients might not be around on the delayed day of the approval.”
http://seekingalpha.com/article/2230...s?source=yahoo