Merck has announced an independent positive assessment of its Erbitux trial and hopes for approval in Europe. The potential market for the colorectal cancer treatment is huge, but Erbitux has a colorful history and Merck may have difficulty distancing the drug from its unfortunate past.
Last Friday, Merck announced that an independent panel had confirmed its positive assessment of an Erbitux trial. In the trial of 330 colon cancer patients Erbitux was tested alone and in combination with chemotherapy. The panel's review confirms that the drug appears effective. Detailed results of the trial will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June.
Merck KgaA has licensed Erbitux from ImClone to develop and market the drug outside the US and Canada. Merck is now confident of meeting regulatory requirements to file for approval in Europe in the middle of 2003 and expects the drug to be on the market by 2004.
Erbitux got huge media coverage in December 2001. The FDA refused to accept ImClone's application to review the drug on the basis of a faulty trial design. But in a meeting in February 2002 the FDA said it would consider reviewing the drug based on Merck's data if it was strong enough. Since then ImClone and its marketing partner for the US, BMS, have been awaiting results from Merck's European trials.
This announcement boosts hopes that ImClone and BMS will be able to provide the necessary data to proceed with their FDA application in the US.
The detailed results of the Merck trial are awaited with eager anticipation. However, it remains to be seen if the FDA will be convinced by the results and pave the way for approval in the US.
With colorectal cancer being one of the major cancers in the Western world, the market for drugs such as Erbitux is large. However, the drug's eventful history, which among other surprising twists led to the downfall of ImClone's former chief executive, may stand against it. Even if approved, Erbitux might still struggle to shake off its negative image.
Related Research: Datamonitor, "Drugs of Tomorrow 2002: Colorectal Cancer" (DMHC1740)
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