Onyx delays US filing for carfilzomib multiple myeloma drug, slightly
This article was originally published in Scrip
Executive Summary
During its second-quarter conference call, Onyx Pharmaceuticals revealed it has pushed back the completion of its rolling new drug application (NDA) submission for its proteasome inhibitor carfilzomib in the US from summer to early fall – a shift the company said would allow it to integrate the recommendations from some newly added external experts, including some former US FDA medical reviewers brought on as consultants.