Navigation Links
Dana-Farber/Provenge: Approval of prostate cancer immunotherapy-new era of cancer treatments
Date:4/29/2010

BOSTONToday's announcement that the U.S. Food and Drug Administration has approved Provenge, a new form of therapy for some prostate cancer patients, marks the beginning of an era in which patients' own immune systems become part of the standard therapeutic arsenal against cancer, say Dana-Farber Cancer Institute investigators who led a study of the treatment's effectiveness in patients.

The study the results of which were presented most recently at the 2010 Genitourinary American Society of Clinical Oncology's annual meeting is the first large, controlled clinical trial to show that an immune system-based therapy can extend the lives of cancer patients, according to the trial's leader, Philip Kantoff, MD, of Dana-Farber.

"For more than 20 years, scientists have been working on harnessing the immune system in a way that has beneficial effects for cancer patients, notably the prolongation of survival," Kantoff said. "Our study provides proof that such an approach can work."

Unlike preventive vaccines, which bolster the immune system to protect people from contracting an illness, Provenge is an "autologous cellular immunotherapy," or a therapeutic vaccine, that marshals the immune system's disease-fighting forces for people who already have prostate cancer.

The immunotherapy is produced by removing some of a patient's white blood cells a process called leukapheresis and then exposing them to a protein from prostate cancer cells and a stimulatory molecule. The process primes the white blood cells to stimulate the immune system and attack prostate cancer when they are re-injected into the body.

The clinical study, a Phase III trial conducted at cancer treatment centers across the country, enrolled 512 patients with advanced prostate cancer that had spread beyond the prostate gland and that grew even when deprived of the hormone androgen, a condition known as metastatic hormone-resistant prostate cancer. Patients were randomly assigned to receive either Provenge, which is manufactured by the Dendreon Corporation of Seattle, or an inactive placebo. Compared to the placebo, Provenge extended a patient's median survival by 4.1 months, improved three-year survival by 38 percent, and reduced the overall risk of death by 22.5 percent.

Approval by the FDA means that Provenge will become available within the next year to prostate cancer patients who meet the criteria of having advanced, metastatic tumors that are hormone resistant. Because of the complexity of making the immunotherapy which must be individually produced for each patient there will be a six- to 12-month ramp-up period before it is available to all eligible patients. Patients should check with their doctors to determine if they're candidates for the vaccine, noted Kantoff, who is the director of the Lank Center for Genitourinary Oncology at Dana-Farber/Brigham and Women's Cancer Center, chief of the Division of Solid Tumor Oncology and chief clinical research officer at Dana-Farber, and professor of medicine at Harvard Medical School.

Every year, more than 192,000 men are diagnosed with prostate cancer in the United States, and more than 27,000 die of the disease, according to the American Cancer Society. The number of men with metastatic, hormone-resistant prostate malignancies who might benefit from Provenge is in the tens of thousands.

Provenge is administered to patients three times over the course of a month. It is designed to fit in with other treatments that patients may be receiving.

"As scientists have learned more about the basic workings of the immune system, they've developed increasingly effective ways to exploit the immune response to cancer," Kantoff said. "Provenge is the first fruit of this endeavor to receive FDA approval the first of what we expect to be many more cancer immunotherapies in the future."

"We are beginning to see the results of years of research into the basic biology of cancer, and of our work to personalize care around the unique characteristics of each patient," said Edward J. Benz, Jr., MD, president of Dana-Farber. "These promising results are a step forward in a long journey."


'/>"/>

Contact: Teresa Herbert
teresa_herbert@dfci.harvard.edu
617-632-5653
Dana-Farber Cancer Institute
Source:Eurekalert

Related medicine news :

1. FDA Approval of new Prostate Treatment Shows Promise of Cancer Immunotherapy
2. Prostate Cancer Vaccine Gains FDA Approval
3. Third European Novel Food Approval Received by Tahitian Noni International
4. Prostate Cancer Vaccine May Get FDA Approval
5. Almac to Improve Label Approval Process in Clinical Trials
6. Mega Stock Picks (megastockpicks.com) Initiates Coverage on FDA Approval for POZEN, Inc.(NasdaqGM: POZN) Drug Vimovo with Immediate Buy Recommendation
7. Yondelis(R) Receives Five New Approvals Outside the European Economic Area
8. Hard to Treat Diseases (HTDS) Acquired Varicella Approval in Guatemala
9. Physician calls for more rigorous standards for drugs up for FDA approval
10. Approval of Kansas Smoke-Free Legislation Is Historic Win for Health
11. FDA Cancer Drug Approval Rate Highlighted in JNCI
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/19/2017)... ... August 19, 2017 , ... ... has joined its Orlando location as an interventional pain management physician. He brings ... on the treatment of migraine headaches, and significant experience in spinal cord stimulation ...
(Date:8/18/2017)... New York (PRWEB) , ... ... ... Courier, LLC, d/b/a Quick International, LLC (“Quick”), a highly specialized asset-light logistics ... it has entered into a definitive agreement to purchase Unitrans International Corporation, ...
(Date:8/18/2017)... O'Fallon, MO (PRWEB) , ... August 18, 2017 , ... ... Charles County, is inaugurating a new charity drive to generate community support for efforts ... for research into cures and treatments for all types of cancer. , Each ...
(Date:8/18/2017)... ... August 18, 2017 , ... The Brian Gifford Agency, ... Indiana, is campaigning in support of Campagna Academy in a charity drive to provide ... “Hoosier Boys’ Town of Indiana,” Campagna Academy is a nonprofit organization that has offered ...
(Date:8/18/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, Texas, ... false teachings pertaining to the mother of the Savior whom the world calls “Mother Mary”. ... picture of the role of this historical woman. , “The world bows, kisses the ...
Breaking Medicine News(10 mins):
(Date:8/15/2017)... Aug. 15, 2017   Mostyn Law and Gulf Coast ... Houston, Texas . The Mostyn Law family has ... years. That is why Mostyn Law is partnering with ... to show its appreciation. Blood supplies are running low. ... short of hospital needs in August. That is why the blood ...
(Date:8/15/2017)... N.C. , Aug. 15, 2017  Axium Pharmaceuticals Inc., the creator ... rumored to be in the beginning stages of an IPO. ... on epilepsy medications with the average cost of a prescription epilepsy drug ... ... Another staggering figure is the fact ...
(Date:8/15/2017)... , Aug. 15, 2017  AOTI Inc. announced today that its ... Inc., has recently opened a New York City Office in ... of its unique Topical Wound Oxygen (TWO 2 ) homecare therapy. ... Accreditation Commission for Health Care (ACHC) under the company,s DMEPOS accreditation ... ...
Breaking Medicine Technology: