Erbitux sBLA for Cancer Indication Withdrawn From the FDA

Erbitux, the cancer drug at the heart of the collaboration between Bristol-Myers Squibb and ImClone, has suffered a setback with the companies’ withdrawal of the sBLA for an additional indication to treat advanced nonsmall cell lung cancer. Bristol-Myers Squibb and Eli Lilly, which owns ImClone, agreed to withdraw the sBLA after consulting with the FDA because of chemistry, manufacturing and controls concerns, but they will resubmit it in the future, according to a statement from the companies.
Washington Drug Letter