Jevtana Approved for Prostate Cancer Three Months Ahead of Expectations

The Food and Drug Administration on today approved the first prostate cancer chemotherapy drug found to extend the survival of men who are no longer being helped by other treatments.
The drug is called Jevtana and it is made by Sanofi-Aventis of France. The FDA approved Jevtana to treat prostate cancer that does not respond to hormone-deprivation treatments or to docetaxel, the cancer drug most commonly used to fight prostate tumors. Earlier this year, a study showed Jevtana prolonged survival for those patients by 10 weeks.
Jevtana was approved for use in combination with the steroid prednisone, which is often used in cancer treatment.
In that study, patients who received a treatment regimen including Jevtana lived for about a year and three months after starting treatment. Those who received standard treatment lived for about a year and three weeks. There is hope the drug will have a stronger effect on patients who are not as sick.
Jevtana is given by injection. In the study, patients on Jevtana were more likely to have their tumors shrink than those who were on standard chemotherapy. However no patients in the study experienced a complete remission, or disappearance of all signs of the disease.
This is the second prostate cancer drug that was approved this year, giving prostate cancer patients new options. Prostate cancer, which usually occurs in older men, is the second-most common cause of cancer death among men in the U.S., behind lung cancer, according to Sanofi.

Sources: Associated Press OnLine, Sanofi-Aventis and Federal Drug Adminsistration

More Highlights on New Cancer Treatments and Studies from the American Society of Clinical Oncology Conference

Chrionic Myeloid Leukemia
Dasatinib (Sprycel) which is made by Bristol-Myers Squibb is effective as an initial treatment for newly diagnosed patients with chronic phase (early stage) chronic myeloid leukemia (CML), according to a phase II clinical trial from The University of Texas M. D. Anderson Cancer Center in Houston.
CML is a cancer of the blood-producing cells of the bone marrow. Patients with CML have an acquired genetic mutation (change) in their bone marrow cells called the Philadelphia chromosome, which produces the BCR-ABL protein. This protein causes the bone marrow cells to grow uncontrollably.
Dasatinib is currently approved as a second-line treatment when imatinib (Gleevec), the standard initial treatment, is no longer effective. Dasatinib and imatinib are targeted therapies that disrupt BCR-ABL. Both medications are given as a pill by mouth.
About ten years ago, Gleevec (manufactured by Novartis SA) was considered an amazing discovery with its ability to prolong lives in this deadly form of leukemia. Another drug called Tasigna, also from Novartis showed promise on CML as well. Soon doctors and patients will have a couple of other alternatives to combat this disease.
Advanced Prostate Cancer
For the first time, a new drug called cabazitaxel helped men with advanced prostate cancer that had stopped responding to standard treatment live longer. Currently, men with advanced prostate cancer receive hormone therapy and when hormone therapy does not work, they receive chemotherapy with the drug docetaxel (Taxotere). When the prostate cancer cells stop responding to treatment with docetaxel, meaning that the drug is no longer able to kill the cancer cells, there is no standard treatment, although mitoxantrone (Novantrone) is commonly used. In this study of almost 1,000 men with prostate cancer no longer responding to docetaxel, men who received cabazitaxel lived longer than men who received mitoxantrone. “There are no effective treatments available to help men with advanced hormone-resistant prostate cancer whose disease continues to grow despite standard chemotherapy, and this large study shows that patients who received cabazitaxel live longer,” said lead author Oliver Sartor, MD, Piltz Professor for Cancer Research at Tulane Cancer Center in New Orleans. “This treatment offers men with this advanced form of prostate cancer a new option.” Cabazitaxel is not currently approved by the U.S. Food and Drug Administration (FDA). The study referenced is a Phase III study. The drug cabazitaxel is manufactured by Sanofi-Aventis.
Metastatic Breast CancerWomen with breast cancer that has spread lived about two and a half months longer when they received a new drug called eribulin mesylate (manufactured by Eisai) compared with patients who received other treatments recommended by their doctors. Currently, there is no standard treatment for advanced breast cancer and this is the first study to look at this drug. Side effects included a low white blood cell count, fatigue, and nerve problems. This drug is not yet approved.
The source of the information in this post is from the conference highlights and related news releases found on the ASCO website (www.cancer.net). Please consult your medical practitioner to confirm and verify the topics discussed herein.

FDA Approves Provenge for Men With Advanced Prostate Cancer

This information is directly from the Dendreon Website (The manufacturer of Provenge)
PROVENGE® (sipuleucel-T) Is Now FDA Approved
PROVENGE is an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is made using cells from a patient's own immune system, so it cannot be warehoused like many other drugs and requires specialized manufacturing facilities.

Within the first year of FDA approval, Dendreon anticipates being able to manufacture PROVENGE to support the treatment of about 2,000 patients. At launch, treatment will be available through approximately 50 centers across the country previously approved as clinical trial sites. As our manufacturing capacity increases over the next 12 months, PROVENGE will become more broadly available.

How It Works

PROVENGE (PROH-venj) is designed to stimulate a patient’s immune system to target prostate cancer cells. The process of making PROVENGE involves the introduction of a patient’s immune cells to a protein that functions as a prostate cancer-associated antigen. An antigen is a substance that causes the body to react with an immune response. This process activates the patient’s immune cells against prostate cancer cells to help the immune system better fight the disease.

Additional information is provided in the FDA news release located on PR Newswire.

This is very exciting news for the cancer community because it is the first cancer immunotherapy product sometimes called an "individualized cancer vaccine" to receive FDA approval.

We have highlighed Dendreon on our Lots To Live For, Inc. Resources Page for many years.

Here is a NY Times article about the Provenge approval.
F.D.A. Approves Vaccine for Prostate Cancer
By ANDREW POLLACK
Published: April 29, 2010
The treatment is the first to use a so-called cancer vaccine that trains the body’s immune system to fight the disease.