FDA advisory committee to review dutasteride as chemopreventive agent
Posted Dec 01 2010 12:00am
An FDA advisory committee will meet today to review data on the potential use of dutasteride for the prevention of prostate cancer. The Prostate Cancer Roundtable (including Prostate Cancer International) issued the following media release yesterday.
Prostate Cancer Roundtable Optimistic that ODAC will Recommend Approval of Dutasteride for Prostate Cancer Prevention
WASHINGTON, Nov. 30, 2010 On Wednesday, December 1, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will hear presentations about the effectiveness and safety of dutasteride in reduction of the risk for prostate cancer in men at greater than average risk of such a diagnosis – and then decide whether to recommend approval of dutasteride for this new indication.
Speaking on behalf of the entire Prostate Cancer Roundtable, Jonathan W. Simons, president and chief executive officer of the Santa Monica-based Prostate Cancer Foundation, said, “We are optimistic that ODAC will send a strong signal to the FDA that the published clinical research on the benefits of dutasteride as an agent for the prevention of prostate cancer in the right patients outweigh the known side effects of this agent. Dutasteride is a drug that has been widely used for treating benign prostatic hyperplasia.”
The ability to significantly reduce lifetime risk for selected forms of cancer is dependent, in part, on our ability to develop and bring to market agents that can clearly reduce that risk in the same way that cholesterol-lowering agents have been able to reduce risk for certain types of cardiovascular disease. To date, only two drugs have ever been approved for the prevention of any form of cancer tamoxifen and raloxifene each of which is approved for the reduction of risk from invasive forms of breast cancer in well-defined patient types.
“It is important to note that prostate cancer can have a devastating effect on entire families,” said Theresa Morrow of Women Against Prostate Cancer. “Just a little encouragement from a spouse or another family member can get a man to his healthcare provider for regular health checks, including prostate cancer testing when appropriate. The approval of a drug that can help to reduce risk for prostate cancer would be another positive message in the continuing battle to improve men’s health.”
The 8,200-patient REDUCE trial was a double-blind, randomized, placebo-controlled, multi-center study that evaluated whether dutasteride at a daily dose of 0.5 mg decreased risk of biopsy-detectable prostate cancer by comparison with a placebo. The patients tested in the REDUCE trial were men between the ages of 50 and 75 who were at increased risk for prostate cancer because of prostate specific antigen (PSA) levels between 2.5 and 10 ng/mL (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL (in men aged greater than 60 years).
Results from the REDUCE trial were initially presented at the annual meeting of the American Urological Association in April 2009 and subsequently reported in the New England Journal of Medicine. They showed that dutasteride lowered the relative risk of developing prostate cancer by 23 percent in men with an increased risk of the disease. The absolute reduction in risk for a diagnosis of prostate cancer associated with dutasteride as compared to a placebo was 5.2 percent.
The REDUCE trial clearly achieved its primary endpoint and demonstrated that dutasteride significantly reduced the risk of biopsy-detectable prostate cancers over a period of just 4 years. A total of 1,516 cancers were identified among the 6,729 men who underwent a biopsy or prostate surgery, with 659 in the dutasteride arm and 857 in the placebo arm.
“The approval of dutasteride for the prevention of prostate cancer represents an important opportunity for men known to be at elevated risk for this disorder,” said Thomas Kirk, president of Us TOO International, the world’s largest, patient-focused, prostate cancer education and support network. “It may only be a first step toward the development of more effective and even safer agents for the prevention of this disease, but it would further validate the concept of chemoprevention for men at risk of one of the most common forms of cancer, thereby encouraging continued research into newer and potentially better agents for the future.”
As prostate cancer continues to strike one in six American men, and with African American men having an incidence rate up to 60% higher than white men, it is important that patients and their physicians engage in a meaningful conversation about prostate cancer, about individual risk for this disease, and about the value of prevention, early detection, and appropriate management.
Wendy Poage, president of the Prostate Conditions Education Council stated, “I cannot over-emphasize the importance for men to engage in an ongoing dialogue with their healthcare providers about their individual risk for prostate cancer and the need for appropriate baseline and follow-up testing. It could mean the difference between living with or dying from this disease.”
About Prostate Cancer
Prostate cancer is the most prevalent form of cancer among American males. Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about 32,000 will die from this disease. Risk factors for prostate cancer are known to include race, family history, elevated PSA levels, positive findings on a digital rectal examination, and selected pathological findings on prior biopsies.
Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under the brand name Avodart®. Dutasteride has previously been approved in the USA and other countries around the world for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. When used in the management of BPH, dutasteride has been shown to improve urinary tract symptoms, to reduce the risk of acute urinary retention, and to lower risk for surgical intervention to resolve symptoms of BPH.
Dutasteride, like all other prescription medicines, is known to be associated with some common and some rare side effects. Common side effects of dutasteride (occurring in less than 5% of patients) include impotence, decreased libido, difficulty with ejaculation, and tenderness or enlargement of the breast. Dutasteride is also known to trigger a rare allergic reaction. Signs of this allergic reaction include a skin rash, hives, and swelling of the eyelids, face, lips, arms or legs.
In the REDUCE trial, men receiving dutasteride had an increased incidence of heart failure (30 events or 0.7 percent) compared to men receiving placebo (16 events or 0.4 percent).
About the Prostate Cancer Roundtable
The Prostate Cancer Roundtable is a group of independent, not-for-profit organizations which cooperate to foster the development of policies supporting the prevention and early detection of clinically significant prostate cancer, the effective treatment of men with this disease, and the appropriate education of all men at risk for this disease.
The above statement has been issued on behalf of and endorsed by
The following organizations join in support of this press release: