According to Dr. Bruce Roth, Professor of Medicine at Washington University School of Medicine, primary hormonal therapy, either by surgical removal of the testicles or the administration of an intramuscular injection with a class of drugs called LHRH agonists, reduces the testosterone level in the blood by about 90-95%, but levels inside tumor cells are reduced only by 40-60%.
This means that their are other sources of testosterone in the body. One source is the adrenal glands, which produce a number of important hormones. Scientists have also discovered that prostate cancer cells themselves can make their own testosterone, and that process of synthesis of testosterone utilizes the same set of enzymes found in the adrenal gland.
Zytiga (abiraterone) blocks one of those enzymes, effectively shutting down synthesis of testosterone, and thus deprives some of the remaining cancer cells of this compound that they need to survive and multiply.
Johnson & Johnson (J&J) won USFDA approval for its prostate cancer pill Zytiga to be used earlier in the disease.
Zytiga can be prescribed before chemotherapy in men whose prostate cancer has spread to other parts of the body and is resistant to testosterone-lowering treatments, the Food and Drug Administration said today in a statement.
The drug extends survival when given before chemotherapy and prolongs the time before patients seek chemotherapy and pain treatments, according to Michael Meyers, J&J’s development team leader for Zytiga.
The approval may expand use by as much as fourfold, Meyers said. About 20,000 men in the U.S. have used the drug since it was cleared in April 2011.
“As we move into earlier stages of disease, what we’re doing is not only prolonging survival, what we are doing is prolonging the time that men with metastatic castration-resistant prostate cancer have good quality of life and are able to maintain their functioning,” Meyers told Bloomberg News.
Prostate cancer is the second-leading cause of cancer death in American men behind lung cancer. About 241,700 new cases will be diagnosed this year and almost 28,200 men will die of the disease, according to the American Cancer Society.
Zytiga decreases the production of testosterone, which stimulates prostate tumors to grow, the FDA said.
Patients in a clinical study who took Zytiga for its new use along with a steroid lived a median of 35.3 months, or 5.2 months longer than those who took a sugar pill in combination with steroids, according to the FDA’s statement.
Patients on Zytiga hadn’t experienced further tumor growth during the study while those on the sugar pill saw growth after a median of 8.3 months.
Provenge was approved for a similar use and could be used with Zytiga and in sequence, Meyers said.
Xtandi was cleared in August by the FDA for patients whose disease has advanced beyond the prostate even with previous treatments.
J&J is studying Zytiga in men with prostate cancer who haven’t yet received hormonal therapy, Meyers said.
Zytiga (abiraterone acetate) is also better absorbed with food, though the label says empty stomach. Some oncologists have been able to reverse Zytiga resistance by having patients take it with a fatty meal.
Zytiga costs $44,000 a year. The drug extended life by an average of less than 5 months to 16 months, according to a company spokesperson.
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This means that their are other sources of testosterone in the body. One source is the adrenal glands, which produce a number of important hormones. Scientists have also discovered that prostate cancer cells themselves can make their own testosterone, and that process of synthesis of testosterone utilizes the same set of enzymes found in the adrenal gland.
Zytiga (abiraterone) blocks one of those enzymes, effectively shutting down synthesis of testosterone, and thus deprives some of the remaining cancer cells of this compound that they need to survive and multiply.
Johnson & Johnson (J&J) won USFDA approval for its prostate cancer pill Zytiga to be used earlier in the disease.
Zytiga can be prescribed before chemotherapy in men whose prostate cancer has spread to other parts of the body and is resistant to testosterone-lowering treatments, the Food and Drug Administration said today in a statement.
The drug extends survival when given before chemotherapy and prolongs the time before patients seek chemotherapy and pain treatments, according to Michael Meyers, J&J’s development team leader for Zytiga.
The approval may expand use by as much as fourfold, Meyers said. About 20,000 men in the U.S. have used the drug since it was cleared in April 2011.
“As we move into earlier stages of disease, what we’re doing is not only prolonging survival, what we are doing is prolonging the time that men with metastatic castration-resistant prostate cancer have good quality of life and are able to maintain their functioning,” Meyers told Bloomberg News.
Prostate cancer is the second-leading cause of cancer death in American men behind lung cancer. About 241,700 new cases will be diagnosed this year and almost 28,200 men will die of the disease, according to the American Cancer Society.
Zytiga decreases the production of testosterone, which stimulates prostate tumors to grow, the FDA said.
Patients in a clinical study who took Zytiga for its new use along with a steroid lived a median of 35.3 months, or 5.2 months longer than those who took a sugar pill in combination with steroids, according to the FDA’s statement.
Patients on Zytiga hadn’t experienced further tumor growth during the study while those on the sugar pill saw growth after a median of 8.3 months.
Provenge was approved for a similar use and could be used with Zytiga and in sequence, Meyers said.
Xtandi was cleared in August by the FDA for patients whose disease has advanced beyond the prostate even with previous treatments.
J&J is studying Zytiga in men with prostate cancer who haven’t yet received hormonal therapy, Meyers said.
Zytiga (abiraterone acetate) is also better absorbed with food, though the label says empty stomach. Some oncologists have been able to reverse Zytiga resistance by having patients take it with a fatty meal.
Zytiga costs $44,000 a year. The drug extended life by an average of less than 5 months to 16 months, according to a company spokesperson.
Only registered and activated users can see links., Click Here To Register...
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