Intermediate Endpoint Proposals For Cancer Immunotherapies Don’t Sway FDA
Executive Summary
An issue brief laying out four potential intermediate endpoints for checkpoint modulators draws a cautious response from FDA representatives at a cancer research conference. The endpoints may prove useful for exploratory purposes but are far from ready to serve as the basis for registration, agency says.
You may also be interested in...
Yervoy Cuts To The Head Of The Line: Ipilimumab Has Unrestricted Label
Bristol-Myers Squibb's immunotherapy Yervoy (ipilimumab) will enter the market positioned for wide use, with a broad label for its approval for metastatic melanoma and positive Phase III results for front-line patients.
Weak Result Stops Pfizer’s Tremelimumab Phase III Trial
Failure casts doubt on Bristol/Medarex’s CTLA-4 inhibitor ipilimumab, analysts say.
Regulatory Flexibility: BrainStorm’s Problematic NurOwn BLA May Be A Bridge Too Far For US FDA
Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.