Bristol/ImClone Pull, Will Resubmit, Erbitux sBLA For Lung Cancer
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
ImClone Systems and Bristol-Myers Squibb are pulling a supplemental BLA for Erbitux (cetuximab) to treat non-small cell lung cancer, saying they plan to resubmit the application as soon as possible after answering manufacturing questions posed by FDA