HER2 Support Group Forums - View Single Post - FDA finds Avastin doesn't extend lives in BC patients... ?

schoonder · 11-17-2010, 07:33 AM

Well, one thing we do know about FDA's thinking is that they have no problems with fact that issuance of RTF could well delay access to an apparent effective drug by some two plus years to people so desperately in need of new options.
If FDA rated T-DM1 of sufficient critical stature, I believe even with RTF related shortcomings that were disclosed, agency's regulations provided them with an out so they could proceed with actual evaluation of the trial data.

"The agency may, for particularly critical drugs, not use the RTF procedure, even where it could be invoked or might review parts of a refused application if it believes that initiating the full review at the earliest possible time will better advance the public health."

11-17-2010, 07:33 AM	#20
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: FDA finds Avastin doesn't extend lives in BC patients... ? Well, one thing we do know about FDA's thinking is that they have no problems with fact that issuance of RTF could well delay access to an apparent effective drug by some two plus years to people so desperately in need of new options. If FDA rated T-DM1 of sufficient critical stature, I believe even with RTF related shortcomings that were disclosed, agency's regulations provided them with an out so they could proceed with actual evaluation of the trial data. "The agency may, for particularly critical drugs, not use the RTF procedure, even where it could be invoked or might review parts of a refused application if it believes that initiating the full review at the earliest possible time will better advance the public health."