FDA approves injectable drug degarelix for advanced prostate cancer
Individuals reporting a history of periodontal disease were more likely to have increased levels of inflammation, a risk factor for heart disease, compared to those who reported no history of periodontal disease, according to an American Journal of Cardiology report available online today. Led by investigators from Columbia University Medical Center and NewYork-Presbyterian Hospital, the
Full Post: Presence of gum disease may help dentists and physicians identify risk of cardiovascular disease
The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.
Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.
Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn’t do this.
“Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA.
Prostate cancer is one of the most commonly diagnosed cancers in the United States . In 2004, the most recent year for which statistics are currently available, nearly 190,000 men were diagnosed with prostate cancer and 29,000 men died from the cancer.
Several treatment options exist for different stages of prostate cancer including observation, prostatectomy (surgical removal of the prostate gland), radiation therapy, chemotherapy, and hormone therapy with agents that affect GnRH receptors.
The efficacy of degarelix was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, a drug currently used for hormone therapy in treating advanced prostate cancer. Degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors.
In fact, nearly all of the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.
The most frequently reported adverse reactions in the clinical study included injection site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.
Degarelix is manufactured for Ferring Pharmaceuticals Inc., Parsippany , N.J. , by Rentschler Biotechnologie Gmbh, Laupheim, Germany.
More than 95 per cent of men who took degarelix for prostate cancer saw their testosterone levels fall dramatically as early as three days after they started treatment, according to a paper in the December issue of BJU International. They also experienced much greater falls in their prostate-specific antigen (PSA) levels at 14 and 28
Full Post: Degarelix prostate cancer drug makes testosterone levels fall dramatically and quickly
The hormone deprivation therapy that prostate cancer patients often take gives them only a temporary fix, with tumors usually regaining their hold within a couple of years. Now, researchers at Johns Hopkins have discovered critical differences in the hormone receptors on prostate cancer cells in patients who no longer respond to this therapy. The findings,
Full Post: Why prostate cancer patients fail hormone deprivation therapy
The report, entitled Cytosolic Phospholipase A2-: A Potential Therapeutic Target for Prostate Cancer, describes the possible role of an enzyme called cPLA2- in prostate cancer and its potential to be a treatment target for prostate cancers that no longer respond to hormone-related therapy. Hormone-related therapy is the first line of treatment for more advanced prostate
Full Post: Theraputic target for prostate cancer
A Phase III clinical trial at New York University is investigating the safety and efficacy of High Intensity Focused Ultrasound (HIFU) for the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT) using the Sonablate(R) 500. Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine and medical monitor for
Full Post: Trial looks at high intensity focused ultrasound for locally recurrent prostate cancer
The U.S. Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication - keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST. GIST is a fairly rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as
Full Post: FDA approves Gleevec (imatinib mesylate) to prevent gastrointestinal stromal tumor