HER2 Support Group Forums - View Single Post - hopeful phase Inew oral drug 4 triple +s stage IVs who failed mult. other treatments

thinkpositive · 01-18-2017, 06:57 AM

Tiffany,

My understanding is that drugs need to go through all phases to obtain FDA approval. This includes phases 1 - 3, new drug review meeting, new drug application, application review, and then drug approval or not. All of this can take years. However, the fact that this drug has been "fast tracked" is promising and would speed up the review process substantially.

Take care,
Brenda

01-18-2017, 06:57 AM	#3
thinkpositive Senior Member Join Date: May 2014 Location: San Diego Posts: 411	Re: hopeful phase Inew oral drug 4 triple +s stage IVs who failed mult. other treatm Tiffany, My understanding is that drugs need to go through all phases to obtain FDA approval. This includes phases 1 - 3, new drug review meeting, new drug application, application review, and then drug approval or not. All of this can take years. However, the fact that this drug has been "fast tracked" is promising and would speed up the review process substantially. Take care, Brenda __________________ 8/2013 Diagnosed IDC Left Breast ER-/PR-/HER2+ Stage 3C, DCIS ER+/PR+/HER2- Right Breast (54 yr) 8/2013 PET/CT scan shows mass in uterues and suprclavicular nodes 8/20/13 Begin 6 rounds TCH chemo, Perjeta added for rounds 4-6 9/2013 After 1st round of chemo, mass in neck and breast no longer able to feel 11/2013 Hysterectomy, mass from PET/CT scan not cancer (adenomylosis) 12/2013 Finished chemo 1/2014 Double mastectomy with chest expanders 1/2014 Pathology report from surgery and SNB show complete pathological response! 3/2014 Finish IMRT radiation 8/2014 Fat transfer to radiated breast 8/2014 Completed 1 yr of Herceptin 10/2014 exchange surgery expanders removed implants placed 6/2015 3D nipple and areola tattoos