Disease-Free Survival In Renal Cancer Raises Questions, But Still Acceptable, ODAC Says
Whether the endpoint can predict overall survival remains unknown, but there is no evidence not to accept it, US FDA advisory committee says.
You may also be interested in...
US FDA Oncologic Drugs Advisory Committee casts tie vote on proposed expansion of Sutent's renal cell carcinoma indication, mirroring debate FDA having internally.
US FDA's Oncologic Drugs Advisory Committee will consider whether positive S-TRAC or negative ASSURE data should guide decision on expanding Sutent's renal cell carcinoma indication.
Conflict of interest waivers for US FDA advisory committee review of sunitinib's supplemental application signal that difference in statistical analyses for disease-free survival could be key area of discussion.