New drugs for prostate cancer


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A group of new drugs is promising to prolong the lives and relieve the symptoms of men with advanced prostate cancer, but could also add billions of dollars to the nation’s medical bills.
Bone-scan images before and after treatment with Cabozantinib. The dark spots are where cancer had spread to bones.
Multimedia
Jenny Mass
Mark Moldanado, a retired postal worker in Omaha, said that Jevtana had helped keep his cancer in check.
In the last 15 months, three new drugs that extended the lives of prostate cancer patients in clinical trials have been approved by the Food and Drug Administration and several other promising medicines are in clinical trials. Before last year, only one drug had been shown to improve survival — docetaxel, which was approved in 2004.
“What a great time it is in prostate cancer,” Dr. Daniel J. George of the Duke Cancer Institute proclaimed earlier this month at the annual meeting of the American Society of Clinical Oncology.
And it’s a great time for the drug makers, with several drugs competing to fill a niche for longer-term survival. Analysts estimate that some of the new drugs, particularly Dendreon’s Provenge and Johnson & Johnson’s Zytiga, could reach annual sales of $1 billion or even much more.
The recently approved drugs and most of those in development are for cases in which the disease has spread beyond the prostate gland and is no longer held in check by hormone therapy.
Men with that late-stage cancer had a median survival of about a year and a half using docetaxel. The new drugs each added two to five months to median survival when tested in clinical trials. Doctors say that men taking more than one of the drugs in succession would be expected to live more than two years.
But the price of these drugs has already stirred concerns about the costs of care among patients, providers and insurers. For example, Provenge costs $93,000 for a course of treatment, while Zytiga costs about $5,000 a month. Another of the new drugs, Sanofi’s Jevtana, costs about $8,000 every three weeks.
With other pricey drugs on the way, said Joel Sendek, an analyst at Lazard, “We could be talking easily $500,000 per patient or more over the course of therapy, which I don’t think the system can afford, especially since 80 percent of the patients are on Medicare.”
Medicare has already fired what some analysts interpret as a warning shot over prices, conducting a yearlong inquiry into whether to pay for Provenge. In its final decision, due Thursday, Medicare is expected to pay for the drug when used according to the label.
Medicare officials denied that price was the reason for the review. But some patient advocates and politicians portrayed the review as a step toward rationing.
Private insurers are also paying only if drugs are used according to the label, according to doctors and patient advocates.
“The reality is, there’s pushback,” said Dr. Oliver Sartor of Tulane University.
Still, for now, one company’s price is prompting the next one to follow suit.
“The pricing environment is encouraging and getting better for us,” Andrew Kay, the chief executive of Algeta, told securities analysts earlier this month, after announcing that his company’s experimental drug had extended median survival nearly three months in a clinical trial.
Mr. Kay said he had initially thought that his company, which is based in Norway, would charge about $25,000 for a typical course of treatment with the drug, Alpharadin. But with the rival drug Jevtana costing about $50,000, Algeta and its partner, Bayer, are considering a higher price.
About 218,000 men in the United States get prostate cancer each year and about 32,000 die, according to the American Cancer Society.
In many cases, the cancer is caught before it has spread beyond the prostate gland and can be cured with surgery or radiation therapy.
If the cancer has spread, men usually are given drugs, particularly Abbott Laboratories’ Lupron, that suppress the body’s production of the hormone testosterone, which can fueltumor growth.
The new drugs, for now at least, are for use when this hormone-deprivation therapy has stopped working.
“This is a small subset of people with prostate cancer,” said Dr. Charles Myers, a prostate cancer specialist in private practice in Charlottesville, Va., who is a survivor of the disease himself. However, he noted, “It’s the group of people who are dying.”
Provenge was approved in April 2010 for patients whose cancer was late-stage but not yet causing many symptoms.
Once symptoms, mainly bone pain, have appeared, men are likely to receive docetaxel, a generic drug also sold by Sanofi as Taxotere .
Two other new drugs are approved for use only after docetaxel has been tried. One, Sanofi’s Jevtana, is a chemotherapy drug in the same class as docetaxel; it was approved in June 2010. The other is Johnson & Johnson’s Zytiga, approved this April.
Many patients and doctors are most enthusiastic about Zytiga and Provenge because they are alternatives to chemotherapy, which many men want to avoid because of side effects. Provenge works by training the body’s immune system to fight the tumor.
Zytiga is a new form of hormone therapy. While Lupron mainly blocks production of testosterone by the testes, there is still some hormone produced by the adrenal gland or even by the tumor itself. Zytiga, by inhibiting an enzyme called CYP17, clamps down on testosterone production.
Doctors and patients say the new drugs can offer some men a decent quality of life, although they are not free of side effects. For instance, Zytiga, also known as abiraterone, can cause hypertension and liver damage and must be taken with the steroid prednisone.
Many men are likely to try several of the drugs. Mark Maldonado, a retired postal worker in Omaha, said that Jevtana had helped keep his cancer in check without debilitating side effects. But knowing that the drug would eventually stop working, he and his doctor “talked about abiraterone being the next step in our progress through the drugs.”
More competition is coming. Takeda Pharmaceutical and Medivation, a San Francisco company, are separately developing other drugs that block testosterone’s production or its effects.
Some of the most exciting advances, doctors say, are in the area of fighting the spread of prostate cancer to the bone. Such bone metastases are very common in men with advanced prostate cancer and account for most of the death and disability from the disease.
Cabozantinib, an experimental drug being developed by Exelixis, seems to be able to virtually eradicate bone metastases in some patients, at least as measured by bone scans, something no other drug has done.
Amgen won F.D.A. approval in November for Xgeva, a drug that reduces the risk of fractures and other problems caused by cancer in the bones. The drug can also delay the spread of cancer to the bones, according to the results of a more recent trial.
Dr. Christopher J. Logothetis, of the M. D. Anderson Cancer Center, predicted further progress.
“It’s beyond the individual drugs,” he said. “One sees a manual now on how to go forward.”

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5-alpha reductase inhibitors (5-ARIs): Label Change – Increased Risk of Prostate Cancer


MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program
5-alpha reductase inhibitors (5-ARIs): Label Change – Increased Risk of Prostate Cancer
Drugs in the 5-ARI class include finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn
ISSUE: FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
BACKGROUND: The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is approved to treat male pattern hair loss.
RECOMMENDATION: Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH). See Drug Safety Communication for a Data Summary and additional information.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:www.fda.gov/MedWatch/report.htm1
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

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El finasteride no provoca efectos oseos a largo plazo


Aunque se ha sugerido que la disminución de los niveles plasmáticos de la dihidrotestosterona que se produce en los pacientes tratados con finasterida podría traducirse a largo plazo en alteraciones óseas, los estudios realizados hasta la fecha, no han mostrado efectos en la densidad mineral ósea o los marcadores de formación y de resorción ósea.
Según un estudio de casos y controles publicado en JAMA no se ha encontrado que finasterida, utilizada en la hiperplasia benigna de próstata, incremente el riesgo de fractura de cadera (OR 0.77, IC95% 0.29-1.00, p=0.04). Se incluyeron 7076 casos (varones mayores de 45 años y con fractura de cadera) y un número igual de controles emparejados por edad y centro médico.
El estudio mostró un riesgo superior de fractura de cadera entre los pacientes con una prescripción reciente de alfa-bloqueantes (en los primeros 30 días: OR 2.04; IC95% 1.19-3.49) que los autores atribuyen al efecto adverso de hipotensión ortostática causado por estos fármacos al inicio del tratamiento.
Fuente: Hemos leido.

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