Cancer: Delcath lands expanded CE Mark for organ-isolating chemo treatment

October 23, 2012 by MassDevice staff

Delcath lands expanded CE Mark approval in the European Union to market its targeted chemotherapy delivery system with a drug commonly used to destroy liver tumors.

Delcath logo

Delcath Systems (NSDQ:DCTH) won expanded CE Mark approval in the European Union for its ChemoSat organ-isolating cancer treatment system, landing indication for a new drug used to target liver tumors.

The E.U. regulatory approval allows Delcath to market ChemoSat for use with doxorubicin hydrochloride, an established chemotherapy agent commonly used to treat hepatocellular carcinoma, the most common primarily malignant liver tumor.

"Doxorubicin is a drug widely used to treat HCC in Asia, which is where we see the market opportunity for our ChemoSat system with doxorubicin injection," president & CEO Eamonn Hobbs said in prepared remarks. "Based upon prior discussions, several potential strategic partners in Asia have indicated that they believe that our ChemoSat system with doxorubicin may be well received by the medical community in the region."

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Having the expanded CE Mark in hand may help the company establish new partnerships in Asia, where more than 550,000 new cases of HCC are diagnosed each year, Hobbs added. The median length of survival for a patient in the intermediate stage of HCC is less than 11 months, he said.

Delcath must still overcome regulatory hurdles specific to China in order to penetrate that market, including conducting local clinical trials in order to obtain approval by the China State Food & Drug Administration, according to a press release.