Bristol/ImClone's Erbitux Could Be A First-Line Head And Neck Cancer Submission
This article was originally published in The Pink Sheet Daily
Companies are also pursuing possible use as a front-line non-small cell lung cancer treatment. The biologic is being studied as fist-line in colorectal cancer as well.
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Erbitux is indicated for treatment of EGFR-expressing, metastatic colorectal carcinoma in combination with irinotecan or as monotherapy. Launch is expected within two weeks using product manufactured at Lonza Biologics facility.
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A draft agreement between industry and FDA that would assess user fees for "advisory review" of broadcast direct-to-consumer ads prior to initial public dissemination had its genesis in the Pharmaceutical Research & Manufacturers of America's DTC guiding principles