DISCUSS: The FDA believes that any potential risk should be offset by a
well characterized and clinically meaningful benefit.Does the current information on
Abraxane without a well designed trial examining both comparative
efficacy and safety provide adequate information and justification for
use in the adjuvant setting?
VOTE: The Sponsor has proposed a development plan that would rely on
safety and efficacy data derived from Abraxane’s approved metastatic
indication and Taxol’s known effect in the adjuvant setting to obtain
marketing authorization for the above adjuvant indication.The sponsor does not plan to conduct a
randomized trial of sufficient size to compare Taxol and Abraxane’s
efficacy and safety in the adjuvant treatment of node-positive breast
Should the Sponsor conduct an adequate and well controlled randomized
trial of sufficient size to characterize Abraxane’s efficacy and safety
in the adjuvant setting?
DISCUSS:If the answer to
question #4 is yes, please discuss potential designs of adjuvant
trials.Please note that efficacy
can be demonstrated either in superiority or non-inferiority trials. In
general, superiority trials produce new standards of treatment.Non-inferiority trials are indirect
measures of efficacy and must preserve a percent (percent retention) of
a known treatment effect of the standard drug (Taxol).The lower the required percentage
retention of the effect, the smaller the trial size; however, the
greater the potential loss of efficacy.