FDA: Erbitux Patients Need More Monitoring

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FDA: Erbitux Patients Need More Monitoring

September 14, 2005: 23:36 p.m. EST

By Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow )-

The Food and Drug Administration said patients being

given Erbitux to treat advanced colon cancer should be monitored to make

sure the magnesium levels in their blood don't fall too low.

Erbitux, a drug that is designed to block a protein involved with cancer

growth, is marketed by ImClone Systems Inc. (IMCL), New York, and Bristol-Myers

Squibb Co. (BMY) based in Princeton, N.J. It was approved by the FDA last

year to treat advanced colon cancer.

The recommendation that patients be periodically tested for electrolyte

imbalances is made in a new drug label for Erbitux that the FDA posted late

Wednesday to its Web site. ImClone and Bristol-Myers sent a letter dated Sept.

13

to health-care professionals discussing the labeling changes.

The companies said patients should periodically be given an electrolyte-

monitoring test during treatment and for at least eight weeks after stopping

treatment with Erbitux.

The recommendation is based on an analysis of 224 patients in on-going

clinical trials which showed that half of them experienced hypomagnesemia, or

low

magnesium levels. About 10% to 15% of cases were severe and required patients

to be treated for the electrolyte imbalance in the blood.

A new specific recommendation that patients being given Erbitux be monitored

for at least one hour following an Erbitux infusion and for longer in some

patients was placed on the drug label. Erbitux already carries a " black box "

warning of serious infusions reactions like breathing difficulties in some

patients. Serious reactions occurred in about 3% of patients, according to

Erbitux's label.

Late last month, ImClone and Bristol-Myers submitted an application with the

FDA to treat head and neck cancer.