Imclone to seek Erbitux OK for head, neck cancer
Key points
- ImClone Systems Inc. and Bristol-Myers Squibb Co. said on Tuesday they plan by the second quarter of 2005 to ask U.S. regulators to approve use of their Erbitux colon cancer drug as a treatment for head and neck cancer.
- The U.S. drugmakers, which split profits from the injectable drug, said they would ask the U.S.
- ImClone and Bristol-Myers said they have already discussed their plans with the FDA and are hopeful the agency will decide on their application on a priority basis, meaning within six months rather than the agency's typical year-long review period.
- The FDA in February approved Erbitux for use against colon cancer following a controversial insider share-trading scandal that landed former ImClone Chief Executive Sam Waksal in prison.
ImClone Systems Inc. and Bristol-Myers Squibb Co. said on Tuesday they plan by the second quarter of 2005 to ask U.S. regulators to approve use of their Erbitux colon cancer drug as a treatment for head and neck cancer.
The U.S. drugmakers, which split profits from the injectable drug, said they would ask the U.S. Food and Drug Administration to approve its use in combination with radiation against head and neck cancer.
ImClone and Bristol-Myers said they have already discussed their plans with the FDA and are hopeful the agency will decide on their application on a priority basis, meaning within six months rather than the agency's typical year-long review period.
The FDA in February approved Erbitux for use against colon cancer following a controversial insider share-trading scandal that landed former ImClone Chief Executive Sam Waksal in prison.
Researchers in June released clinical data showing that Erbitux controlled head and neck cancer better than radiation alone and helped some patients live longer.
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Written and revised by
Gerald Hurowitz, M.D.
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