FDA Asks Dendreon to Stop Enrolling Patients in Trials - TheStreet

Biotech firm



said the FDA has asked it to suspend patient enrollment in its second Phase III clinical trial of Provenge, a new prostate cancer treatment, as the regulatory agency seeks clarification about the drug's cellular composition.

Dendreon said the FDA is specifically looking for information about the composition of cellular components used to make the vaccine and the request does not relate to a safety concern. Patients already enrolled in the Phase III trials of the drug will continue to be treated normally.

In a press release, the company said, "We believe our response to the FDA will adequately address their questions." Dendreon also noted that the FDA action will have "no impact on the final analysis of the first Phase III clinical trial," and the company reiterated that the efficacy results from that trial will be available by the middle of the year.


previously said that a preliminary analysis of the results from that first trail were inconclusive, and the drug may not meet its effectiveness goal.

Shares of Dendreon closed at $4.33 before the news Tuesday.