It was announced that some dosages Provenge (sipuleucel-T) did not meet the potency release specification for CD54 upregulation, an error that might affect the ability of Provenge to kick-start the immune system. This quality control error affected less than 0.3% of Provenge’s commercial doses released since its commercial launch.

Dendreon has agreed with the Food and Drug Administration (FDA) to notify certain physician customers starting yesterday, December 19, 2013 of this quality control error. This notice will state that in error Dendreon released, in limited circumstances, one or more doses of Provenge with an inadequate CD54 upregulation. CD54 upregulation is a measure of antigen presenting cell activation that is one of two product potency measurements they use to insure the product potency. Prior to shipping back the activated cells Dendreon is supposed to confirm that there is adequate CD54 upregulation.

As a result of this error certain doses of Provenge which were given to men with metastatic castrate resistant prostate cancer may not have been effective or as effective for the approved indication. This error should not present any direct danger to anyone who might have received the affected treatment.
All other release specifications for the product were met.

Because of HIPPA regulations Dendreon has only patient identifier numbers, not names or contact information of the men who received the problemic treatments. As a result Dendreon will be informing the prescribing physicians about the problem as well as the specific patient identifier numbers of the men receiving the problematic treatments. The notification is limited to those physicians who had patients that were affected.

Dendreon did promptly correct and report to the FDA the issue when they discovered it. The FDA has not placed any restrictions on Dendreon’s ability to manufacture or distribute Provenge. Dendreon is conducting a review of all of its quality control systems to learn why there was this error and to insure that it will not be repeated.

Additionally, Dendreon has told me that in circumstances that a prescribing physician feels it is in the best interest of the patient they will arrange for re-infusions of Provenge at no cost to the patient.

BOTTOM LINE
If you have received Provenge since its approval, contact your doctor and find out if you have received a dose that was affected. If you did, discuss the merits of having a re-infusion.

See: FDA
Form 8-K

Joel T. Nowak, M.A., M.S.W.