LOS ANGELES, Aug 24 (Reuters) – Dendreon Corp. said on Thursday that it has filed the safety and efficacy portions of a U.S. Food and Drug Administration application for an experimental prostate cancer drug and expects to submit the chemistry and manufacturing segment by the end of the year.
“We will apply for a priority review, which means a 6-month clock for the FDA. We could get approval in mid-2007,” said Chief Executive Mitchell Gold.
Seattle-based Dendreon is seeking clearance to market Provenge, which is designed to work by stimulating a patient’s immune system against cancer cells, as a treatment for men with late-stage prostate cancer.
If approved, the drug would be the first therapeutic cancer vaccine.
In one Phase III trial of 127 men with advanced prostate cancer, those taking the drug showed a median survival benefit of 4.5 months compared to the group receiving a placebo.
The drug’s side effects, mainly fever and chills, were shown to be minimal, Gold said.
The company is conducting a third pivotal-stage trial of Provenge in men with advanced prostate cancer as well as a pivotal-stage trial in men with early-stage cancer.
Gold said Dendreon plans to market the drug in the United States and to partner the drug for sales in other markets.
