FDA Approves First Prostate Cancer Drug in Years:
Degarelix for Men with Advanced Cases
Company waiting for a trade name before beginning
marketing in U.S.
Dec. 31, 2008 An injectable drug, degarelix,
became the first new drug approved in several years by the Food and Drug
Administration for the treatment of prostate cancer. Degarelix, however,
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.
Potential trade names are still under review with
the FDA, according to Ferring. Following issuance of a trade name,
Ferring Pharmaceuticals, USA will immediately begin marketing in the
U.S.
On December 18, the Committee for Medicinal
Products for Human Use (CHMP), part of the European Medicines Agency (EMEA),
recommended granting a marketing authorization for degarelix in Europe.
Degarelix is awaiting approval in other key global markets. It is a
milestone for the company and represents Ferring's first global product
launch.
Degarelix is the only GnRH receptor antagonist
approved by the FDA for the treatment of hormonally-sensitive advanced
prostate cancer. Degarelix achieves medical castration differently than
LHRH agonists, specifically by binding reversibly to GnRH receptors on
cells in the pituitary gland, quickly reducing the release of
gonadotropins and consequently testosterone.
"Degarelix was discovered in San Diego, developed
by Ferring Pharmaceuticals in the U.S. and Europe, and in its pivotal
Phase III study demonstrated both an immediate onset of action and a
profound long-term suppression of testosterone and PSA," commented Dr.
Pascal Danglas, Executive Vice President Clinical & Product Development,
at Ferring.
Dec.
2, 2008