Delcath: Safety Questions Behind FDA Delay

Once Delcath resubmits its chemosaturation system for FDA approval, the agency will first decide if the bolstered application is acceptable for review, then regulators will begin the process of formally weighing the efficacy and safety data in order to make an approval decision. A September resubmission could lead to a March 2012 FDA approval decision.ø

Data from the phase III study were presented last June at the American Society of Clinical Oncology (ASCO) annual meeting. In that study, 61% of patients treated with melphalan via the chemosaturation system reported moderate to severe neutropenia, a condition of abnormally low white blood cells that can lead to serious infections.

Another 74% of Delcath-treated patients in the phase III study reported moderate to severe thrombocytopenia, or an abnormally low level of platelets that can result in bleeding.

The mortality rate in the phase III study attributed to treatment with Delcath's system was 7.5%. Two patients died due to neutropenic sepsis while a third patient died from liver failure, according to the ASCO data presentation.

When these safety data were presented last June, concerns were raised that perhaps the high dosages of melphalan used were leaking out of the liver and causing severe side effects and toxicity in patients. Hobbs disputes that concern, insisting Tuesday that the safety profile of melphalan as used in the chemosaturation procedure is "identical" to the safety of melphalan already approved today.

Delcath conducted the phase III study of the chemosaturation system under a Special Protocol Agreement with the FDA. Regulators have not questioned or challenged the conduct of the study, Hobbs said.

Melanoma patients with cancer in the liver treated with Delcath's system went a median of 245 days without progression of those liver tumors compared to 49 days without progression for patients treated with best alternative care. Those data satisfied the study's primary endpoint with statistical significance but a key secondary endpoint of the study -- an improvement in overall survival -- was not met.

The lack of a survival benefit demonstrated by Delcath's chemosaturation system was a point of criticism by a researcher who critiqued the phase III data at last June's ASCO meeting.

--Written by Adam Feuerstein in Boston.



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