FDA Approves Drug for Patients with Advanced Prostate Cancer

The U.S. Food and Drug AdministrationThe 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.

Most Popular Now

Pfizer and BioNTech complete submission to Europea…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted biva...

AstraZeneca to acquire TeneoTwo and its clinical-s…

AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluatio...

Lilly will supply an additional 150,000 doses of b…

Eli Lilly and Company (NYSE: LLY) announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately...

Bayer to sell men's health product Nebido™ to Grün…

Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price ...

Demonstration of a potent, universal coronavirus m…

The SARS-CoV-2 that causes COVID-19 has killed 6.3 million people worldwide since 2019, painfully highlighting the vulnerability of humanity to novel coronaviruses. Re...

Vaccine protection against COVID-19 short-lived, b…

Since COVID-19 vaccines first became available to protect against infection and severe illness, there has been much uncertainty about how long the protection lasts, and w...

SARS-CoV-2 hijacks nanotubes between neurons to in…

COVID-19 often leads to neurological symptoms, such as a loss of taste or smell, or cognitive impairments (including memory loss and concentration difficulties), both dur...

Anti-inflammatory compound shows potential in trea…

An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chanc...

Pfizer and BioNTech advance COVID-19 vaccine strat…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to...

Vaccine-induced immune response to omicron wanes s…

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substan...

Scientists develop new biomimetic formulation for …

Glioblastoma multiforme (GBM) is an aggressive brain cancer with a poor prognosis and few treatment options. New and effective approaches for GBM treatment are therefore ...

New needle-free nasal vaccine shows promise for CO…

New research shows that a needle-free mucosal bacteriophage (phage) T4-based COVID-19 vaccine is effective against SARS-CoV-2 infection. The findings were published in mB...