HER2 Support Group Forums - View Single Post - Fda has approved perjeta for neoadjuvant use!!

phil · 10-02-2013, 02:04 PM

I am excited that this drug will be available at the outset of dx and tx for her2 bc. But it is Still Denied to Stage IV's . Thanks to this Slow , Piece - meal FDA approval process with Perjeta . I know for a fact that Ins. co's are denying Stage IV appr. for Perjeta. BC/BS of the NW for one. Based on it not being fda approved for Stage IV. How many more yrs ??
maybe I'm just suspiscious, but PCR is one of FDA head Dr. Pazdours' " pet stats . he has written on it. he is the architect of the FDA slow -down of approvals, , starting in 2009 . he has championed replacing time to progr., TTP, and progr.- free survival, PFS with overall survival stats , OS. this slows down approval time , even as the drugs get better , and many are genetic, with fewer s/e.
OS , PCR leave a bad taste in my mouth , I think of how his focus on OS has actually led to LESS SURVIVAL. in the cases of T DM-1 and pertuzumab, so far.

10-02-2013, 02:04 PM	#4
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: Fda has approved perjeta for neoadjuvant use!! I am excited that this drug will be available at the outset of dx and tx for her2 bc. But it is Still Denied to Stage IV's . Thanks to this Slow , Piece - meal FDA approval process with Perjeta . I know for a fact that Ins. co's are denying Stage IV appr. for Perjeta. BC/BS of the NW for one. Based on it not being fda approved for Stage IV. How many more yrs ?? maybe I'm just suspiscious, but PCR is one of FDA head Dr. Pazdours' " pet stats . he has written on it. he is the architect of the FDA slow -down of approvals, , starting in 2009 . he has championed replacing time to progr., TTP, and progr.- free survival, PFS with overall survival stats , OS. this slows down approval time , even as the drugs get better , and many are genetic, with fewer s/e. OS , PCR leave a bad taste in my mouth , I think of how his focus on OS has actually led to LESS SURVIVAL. in the cases of T DM-1 and pertuzumab, so far.