AI
Sunday, January 12, 2014 10:06:01 AM
I can see the company now setting the wheels in motion for AA. Now that FT has been approved, the FDA FT guidelines say this.
http://www.fda.gov/downloads/Drugs/Guidances/ucm079736.pdf
Here's slide 63 from this FDA "Oncologic Drugs Advisory Committee" meeting.
"Accelerated approval should be considered for OR>10% 2nd line phase II and >8% 2nd line phase III"
http://www.fda.gov/ohrms/dockets/ac/03/slides/4009S1_06_Bunn.ppt
ORR is a secondary outcome measure for the bavi phase 3 trial. The ORR result for the 3 mg/kg arm in the phase 2 trial was 17.1%.
As soon as possible, if there are plans to study a surrogate endpoint suitable for review under the accelerated approval provisions, a discussion of and support for the proposed endpoint
http://www.fda.gov/downloads/Drugs/Guidances/ucm079736.pdf
Here's slide 63 from this FDA "Oncologic Drugs Advisory Committee" meeting.
"Accelerated approval should be considered for OR>10% 2nd line phase II and >8% 2nd line phase III"
http://www.fda.gov/ohrms/dockets/ac/03/slides/4009S1_06_Bunn.ppt
ORR is a secondary outcome measure for the bavi phase 3 trial. The ORR result for the 3 mg/kg arm in the phase 2 trial was 17.1%.
