FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

Original Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm

CVS Pays $77.6 million in Fines and $2.6 million in penalty fees

CVS Pharmacy, Inc., has reached an agreement with federal prosecutors and will admit to unlawful sales of pseudoephedrine to criminals who made methamphetamine, according to a DEA news release. CVS will pay $75 million in civil penalties—the largest penalty ever paid under the Controlled Substances Act—and forfeit the $2.6 million in profits earned as a result of those drug sales.

DEA reported that CVS Pharmacy, a subsidiary of CVS Caremark Corporation, failed to ensure compliance with laws limiting pseudoephedrine sales, allowing criminals to obtain this ingredient used in the manufacture of methamphetamine. DEA alleged that between September 2007 and November 2008, CVS “supplied large amounts of pseudoephedrine to methamphetamine traffickers in southern California, and the company’s illegal sales led directly to an increase in methamphetamine production in California.”

According to DEA reports, the stores selling pseudoephedrine illegally were located primarily in Los Angeles County and Orange County, CA, and Clark County, NV. While CVS eventually changed practices to prevent these illegal sales, DEA alleged that “it did so only after it became aware of the government’s investigation.”

The Combat Methamphetamine Epidemic Act of 2005 limited the amount of pseudoephedrine a customer can purchase in one day. In 2007, CVS implemented an automated electronic logbook to record sales of the drug, but the system did not prevent multiple purchases by a single customer on the same day, according to DEA. This allowed customers to make repeated purchases of pseudoephedrine that exceeded federal daily and monthly sales limits, the agency reported.

As part of the agreement, the government will not pursue criminal charges against CVS. CVS will accept responsibility for the illegal conduct and implement a compliance and ethics program over the next 3 years. The company also entered into a separate 5-year compliance agreement with DEA. The settlement addresses CVS’s liability in 25 states, including California and Nevada, where CVS failed to implement appropriate safeguards.

APHA Link: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&Template=/CM/ContentDisplay.cfm&ContentID=24469

DEA News release: http://www.justice.gov/dea/pubs/states/newsrel/2010/la101410.html