Pazdur's pitfalls prevention plan: lessons of cancer NDA failures
This article was originally published in Scrip
With the speed at which cancer drugs like Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor Opdivo (nivolumab) and Amgen's bispecific T-cell engager (BiTE) antibody Blincyto (blinatumomab) gained the FDA's approval in recent months, one would think winning over the agency's oncology reviewers has become almost effortless – or at least, a lot easier than it used to be.
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