I'm more than willing to view Delcath's CS data as strong enough for approval since the bear thesis focuses more on the commercial market than efficacy and safety. With that said, two patients treated with the CS procedure died from neutropenic sepsis. Likely, this means some of the ultra-high dose of the chemotherapy melphalan used to kill liver tumors escaped the filters in the CS device and got into the patient's blood stream.
The FDA previously placed Delcath's CS clinical trial on hold due to a safety issue. That hold was lifted and the study was completed, but the disclosure of the two deaths from neutropenic sepsis may concern FDA enough to delay the system's approval until the agency is satisfied that the melphalan filters are doing the job.
Delcath said this week that the FDA approval filing will be completed in October. Assuming a six-month review, the FDA's approval decision date will come next April. Before that, expect an FDA advisory panel to review the CS data.
Next week: Non-ASCO questions! Promise.-- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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