Dendreon’s Provenge Approval Sparks New Era for Cancer Vaccines

Dendreon Corp. won approval for its only product, the prostate cancer vaccine Provenge, concluding a three-year battle with U.S. regulators to introduce the first therapy to train the body’s immune system to destroy tumors.

Provenge may reap annual sales of $4.3 billion by 2020, said George Farmer, a Canaccord Adams Inc. analyst in New York. Its clearance will also benefit more than a dozen other companies developing drugs in the emerging field of cancer immunotherapy, said Joseph Pantginis, an analyst with Roth Capital Partners in New York.

“This approval represents the first cancer immunotherapy product approved in the U.S. and is truly a landmark event,” Pantginis said in a research report yesterday.

Provenge, cleared yesterday for use against advanced prostate tumors, will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011, Seattle-based Dendreon said in a statement. It will cost $93,000 for a typical three- dose course of treatment, the company said.

Food and Drug Administration approval of Provenge “will definitely inform the clinical development programs of other companies” working on vaccine treatments for cancer, said Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston, in a telephone interview before the decision was announced.

The most advanced of these vaccines include Seattle-based Oncothyreon Inc. and German drugmaker Merck KGaA’s Stimuvax for breast and lung malignancies; ipilimumab from Bristol-Myers Squibb Co. of New York, for melanoma; and British drugmaker Oxford BioMedica Plc’s TroVax for prostate and kidney cancer.

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FDA Approves Prostate Cancer Drug

Degarelix, a new drug for treatment of prostate cancer, the second-leading cause of death among men in the U.S., has gained FDA approval.

A gonadotropin releasing hormone (GnRH) receptor inhibitor, the drug is intended to treat patients with advanced cancer, and slows the growth and progression of the cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer, according to FDA officials.

The drug's efficacy was reportedly 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, according to the FDA.

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.

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.

According to the FDA, nearly 190,000 men were diagnosed with prostate cancer and 29,000 men died from the cancer in 2004.

Degarelix is manufactured for Ferring Pharmaceuticals Inc., Parsippany, NJ, by Rentschler Biotechnologie Gmbh, Laupheim, Germany.

Older Adults Mixing Medications

A study published in JAMA has found older adults are routinely mixing their medications.
According to researchers at the University of Chicago Medical Center, nearly one in 25 people ages 57-85 have taken dangerous combinations of drugs with the potential for serious interactions. For men ages 75-85, there are as many as one in 10.

Researchers studied the medication use of 3,500 people living independently across the country to create a representative sample, according to the study, which claims some 2.2 million people are at risk of taking dangerous medication combinations.

About one-third of older adults use five or more prescriptions, and about half use over-the-counter medications and dietary supplements, the study found.

More than half of older adults used five or more prescription medications, over-the-counter medications or dietary supplements while 29 percent took more than five prescription medications.

The report also found that U.S. adults over the age of 65 are taken to the ED more than 175,000 times each year because of dangerous reactions to medications.

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New Prostate Cancer Drug Promising in Early Trials

It’s early in the process, but researchers say early trials of a new drug for treating advanced prostate cancer are producing encouraging results.

Preliminary findings from Phase 1 and Phase 2 tests of the drug, called MDV3100, have shown treatment can reduce chemicals in the blood that indicate the presence of cancer. In the first study of 30 patients treated with the drug, 13 showed declines of the chemicals of more than 50 percent, said a team of researchers led by Charles L. Sawyers of Memorial Sloan-Kettering Cancer Center in New York.

A Phase 3 trial, which will include more test subjects, must still be conducted before the drug can be approved.

MDV3100 is for prostate cancer that has spread to other parts of the body, or metastasized. Treatment of metastasized cancers commonly includes drugs that inhibit the activity of male hormones, which are responsible for powering tumor growth. However, some tumors are becoming increasingly resistant to the drugs.

MDV3100 is different in that it works by binding to receptors for the male hormones, which allows the hormones to retain their cancer-fighting abilities, researchers said.

Prostate cancer is the second-most common form of cancer among Americans, behind only skin cancer. According to the American Cancer Society, more than 186,000 new cases of prostate cancer are diagnosed in the United States each year and about 28,660 men die annually due to the disease. About one in six American men will get prostate cancer during his lifetime and one in 35 will die from the disease.

Source : www.attorneyatlaw.com

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