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Delcath Says FDA Extends Cancer System Review

Mon, 04/08/2013 - 10:33am
The Associated Press

Delcath Systems Inc. said Monday that the Food and Drug Administration will take an extra three months to review its experimental treatment for liver cancer.

The company said the FDA will make a ruling on its Melblez system by Sept. 13. The FDA had asked Delcath for more information about the system, and the agency will use the additional time to review that information.

Melblez is designed to treat cancer by delivering high doses of the chemotherapy drug melphalan directly to the liver while controlling exposure of the rest of the body. Delcath has asked the FDA to approve the system for use in the treatment of inoperable ocular melanoma, a cancer of the eye, when it spreads to the liver.

The system is available in Europe under the name Chemosat.

Delcath shares lost 9 cents, or 5.1 percent, to $1.68 in morning trading.

The FDA had been scheduled to make a ruling by June 15. Delcath said a cancer drug advisory panel will meet to discuss the system on May 2. A favorable review could improve the chances Melblez will be approved, although the FDA is not required to follow the advice of its panels.

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