Dendreon: Prostate Cancer Vaccine Edges Closer to the Market
Posted on: Wednesday, 15 November 2006, 06:00 CST
Dendreon is seeking US marketing approval for its therapeutic cancer vaccine Provenge, for the treatment of advanced prostate cancer. Given the high unmet need in this indication, its approval would be enthusiastically welcomed, while its position as the only cancer vaccine in this market would give Dendreon a first-in-class advantage.
Prostate cancer is the third most common cancer worldwide. In the US alone, more than one million men have the disease, with an estimated 232,000 new cases diagnosed each year. More than 30,000 men die each year of prostate cancer. Provenge (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system.
The Biologics License Application submission for Provenge was based on results from a randomized placebo-controlled phase III trial. The study showed that patients with asymptomatic metastatic hormone-refractory prostate cancer (HRPC) who received Provenge had a median survival time 4.5 months longer than those in the placebo arm. The vaccine also demonstrated a 41% overall reduction in the risk of death. In addition, 34% of patients receiving Provenge were still alive 36 months after treatment compared to only 11% of patients randomized to receive placebo.
While these findings are promising, the design of the phase III trial may raise some questions. Specifically, in the hormone-refractory setting, some asymptomatic patients would now be prescribed Taxotere (docetaxel; Sanofi-Aventis) and it could be argued that if the pivotal phase III trial was initiated today it would be designed to compare the combination of Provenge and Taxotere against Taxotere in combination with prednisone.
To date, no therapeutic cancer vaccine has reached the US market. While this places Provenge in a strong position to achieve a first-in-class advantage, the drug may face a number of hurdles. With no precedent for approval of a cancer vaccine and with potential competition from follow-on pipeline products, Dendreon will need to work hard if they are to capitalize and build on Provenge's clinical promise.
Source: Datamonitor
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