HER2 Support Group Forums - View Single Post

phil · 09-23-2013, 07:52 AM

lani, I know i responded to one of your posts on perjeta. and i too greatly appreciate your research and sharing of info.
This FDAs' ( post 2009) mis - handling of t dm-1 was the major screw -up that only highlighted the slowness of the System . With perjeta , we are back to " business as usual ", yrs and yrs of slow , piece-meal appr. while stage ivs die !
way back in june, 2012, this FDA gave appr. for perjeta for pts , " who have NOT recieved ANY anti-her2 therapy " , first -line. shutting out the stage ivs who sacrificed in the phase I trials of all these drugs, to get it to any further testing. now we see a panel recommending it for neo- adj. and still Stage IV's are shut out ! its infuriating . even the article sub title you cite infuriates me - the superficial media coverage , " Perjeta, which seems to shrink her2 + bc tumors, , might gain " QUICK " FDA approval "... and on that FDA ODAC panel , " our " only spokespeople are bc action , who are pro-FDA biased at this point , a group that actually wrote the FDA asking them to deny early appr. to t dm-1 ! They do not represent Stage IV !

09-23-2013, 07:52 AM	#16
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: FDA Decision Re Perjeta lani, I know i responded to one of your posts on perjeta. and i too greatly appreciate your research and sharing of info. This FDAs' ( post 2009) mis - handling of t dm-1 was the major screw -up that only highlighted the slowness of the System . With perjeta , we are back to " business as usual ", yrs and yrs of slow , piece-meal appr. while stage ivs die ! way back in june, 2012, this FDA gave appr. for perjeta for pts , " who have NOT recieved ANY anti-her2 therapy " , first -line. shutting out the stage ivs who sacrificed in the phase I trials of all these drugs, to get it to any further testing. now we see a panel recommending it for neo- adj. and still Stage IV's are shut out ! its infuriating . even the article sub title you cite infuriates me - the superficial media coverage , " Perjeta, which seems to shrink her2 + bc tumors, , might gain " QUICK " FDA approval "... and on that FDA ODAC panel , " our " only spokespeople are bc action , who are pro-FDA biased at this point , a group that actually wrote the FDA asking them to deny early appr. to t dm-1 ! They do not represent Stage IV !