Zarnestra Phase III Data Needed Pre-Approval, Oncology Committee Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Oncologic Drugs Advisory Committee votes 7 to 4 against recommending accelerated approval of J&J's tipifarnib. Data from the Phase III trial are necessary to identify the appropriate patient population for the oncologic, members say.
You may also be interested in...
FDA Advisory Committees Are Platform For Politicized Discussion, Former Counsel Troy Says
Committee members are using the meetings to “bash the agency,” Troy said.
FDA Advisory Committees Are Platform For Politicized Discussion, Former Counsel Troy Says
Committee members are using the meetings to “bash the agency,” Troy said.
J&J Zarnestra Receives “Not Approvable” Letter From FDA
Oral leukemia agent is not approvable based on Phase II clinical trials, the agency said. J&J maintains it is committed to developing tipifarnib and will determine “appropriate next steps.”