An advisory panel on Wednesday recommended that U.S. health regulators reject the use of Amgen Inc’s drug Xgeva to delay the spread of prostate cancer to the bone, dimming the chance of a wider use for one of the company’s key growth drivers.

The outside advisers to the Food and Drug Administration voted 12-to-1 that the benefits of the injectable drug, known chemically as denosumab, did not outweigh the risk of developing a jawbone-destroying condition.

Xgeva is already approved to prevent fractures and related problems in advanced prostate cancer that has spread to the bone, and the company is seeking additional approval for use of the drug to delay or prevent the spread.

The drug did delay the spread of cancer to the bone by a little longer than four months in a clinical trial of 1,432 men with prostate cancer who had stopped responding to hormone therapy.

But about one in 15 men who took the drug developed osteonecrosis of the jaw, a severe side effect in which jawbone tissue dies, exposing the bone. that rate is far higher than has been seen with widely used osteoporosis drugs.

“If you ask a patient, ‘Do you want to delay your disease by five minutes, but get significant toxicities?’ I think that would give them pause,” said panel member Maha Hussain, a professor of medicine in the hematology and oncology division at the University of Michigan.

The FDA usually follows the recommendations of its expert panels and will make a final decision by April 26.

Most analysts had expected the unfavorable panel vote because the FDA had questioned whether delaying the spread of cancer to the bone was a meaningful benefit to patients given that the drug did not help men live longer or delay the growth of prostate cancer..

“We believe the panel recommendation reinforces the FDA’s view, which has been consistently negative, and approval is unlikely,” said Geoff Meacham, analyst at JP Morgan, in a research note.

However, he said the risk of a rejection of wider approval for Xgeva had only a modest risk to his long-term revenue estimates for Amgen, the world’s largest biotechnology company.

Benefits to patients?

Xgeva and a related osteoporosis drug Prolia are seen as among the most important growth drivers for Amgen and are expected to help offset declining sales of the anemia drugs that had been the company’s backbone.

In the fourth quarter of 2011, sales of Xgeva rose to $134 million from $100 million in the prior quarter, and it is expected to eventually become a $1 billion-a-year drug.

The company said the new use for Xgeva would be targeted at about 50,000 men in the United States at that advanced stage of the disease.

Panel members questioned whether using the drug earlier actually benefited patients, as many did not have symptoms of the disease, but would suffer any drug-related side effects.

However, the patient representative on the panel voted in favor of approval.

“There isn’t a treatment that a man with prostate cancer gets that doesn’t have devastating effects on his masculinity and his quality of life,” said James Kiefert, of Olympia, Washington. “In my opinion, the men who would be candidates for this treatment would be standing up and cheering another option for them.”

His views echoed the favorable comments of several urologists, who testified in favor of the drug during the public hearing.

Amgen said Xgeva provided a meaningful benefit to prostate cancer patients by preventing the spread of their disease to the bones, which is not uncommon.

“We look forward to further discussions with the FDA as they continue to review our application,” the company said in a statement after the vote.

If Xgeva gains wider approval, it would be the first drug to delay the spread of prostate cancer to the bone, Amgen said.

Amgen said it was also testing Xgeva in other cancers, including breast and lung cancer and the blood cancer multiple myeloma.

Q: What is a dental implant?

A dental implant is a metallic root of a tooth. Placed in the jawbone by a dentist dental implants and allows the healing of the bone for a period of time until the bone-implant union is strong enough to support a dental prosthesis. the implant is made of titanium, a metal that is well tolerated by the human body.

Q: how is used to replace missing teeth?

A: When using a dental implant to replace missing teeth, your dentist will determine if there is enough supporting bone to place dental implants to safely support a dental prosthesis. the implant is placed into the bone in a very specific surgical procedure to ensure that the implant will not be rejected by your body. in order to place the implant in the bone, cut the gum tissue. the gum tissue is usually stitched on either the implant or around the implant after it is placed into the bone. the implant will be allowed to heal in the bone for several months until the union is strong enough to support the denture.

Q: What kind of dentist do I have to do?

A: any dentist can place or restore dental implants. Dental implants are usually placed by oral surgeon, periodontist, prosthodontist or general practitioners. Prosthodontists and general practitioners will usually be the restoration of the “teeth.” You should start by talking to your doctor or a prosthetist and determine the amount of experience and training they have in the general field of Dental Implantology. If you choose to go with one of these professionals, you can follow your recommendation as to who really put your dental implant.

Q: how much do implants cost?

A: Usually around $ 1500 to $ 2000. Talk to your dentist.

Q: Are dental implants a permanent solution to tooth loss?

A: If dental implants are considered a permanent solution. there are, however, some caveats … Sometimes, the implant does not integrate and lost. in such cases, another implant can be placed that would stay there and become permanent. Sometimes, the restoration will need to be repaired or serviced … as a matter of fact, most restorations require some maintenance and replacement, sometimes over a period of time. You should be prepared for future expenses in this regard.

Q: Are there people who can not get dental implants?

A: Most everyone can have dental implants placed, but there are some exceptions and caveats of some … Patients who are uncontrolled diabetics or have severe psychological problems are not good candidates for dental implants. Patients with medical problems are not good candidates for anything involving surgery although the dental implant procedures can usually be performed under local anesthesia and are therefore less risky than surgical procedures requiring general anesthesia.

Patients who lack a lot of bones are not good candidates, but bone grafts can be used to replace lost bone and allow the patient with dental implants. You should discuss carefully with your dentist and find out how good you are a candidate for dental implants. If there are things that will make you a better candidate, you must understand and help make the decision whether to take place.

Those who require significant bone grafts for implant placement should hire the services of a qualified oral surgeon. Many bone grafts can be achieved under any competent dentist dental implant placement.

7 how to avoid problems with dental implants.

# 1. find out who has implants and ask them did and the way it came out.

# 2. Search ADA qualified specialists, preferably a certified prosthodontist, for treatment. this area is very demanding and requires specialized training.

# 3. get a detailed, written treatment including all fees and make sure no hidden costs.

# 4. get a second consultation to help you evaluate the first.

# 5. Ask your dentist for the names of patients he or she has sought and the names of other dentists working. call them and find out what you can about the type of work this dentist does.

# 6. Determine the commitment that this dentist has to dentistry and dental implant area. does he or she teaches? does he or she published articles in dental literature. is he or she considers an “expert” in this area of ??treatment.

# 7. find someone who is safe, prudent and careful in their approach to their dental work.

# 8. call the state board of dentistry and find out if there are faults against nurses in relation to their dental practice.

# 9. Do not be afraid to ask many of the procedures the dentist has been successful.

# 10. Ask your dentist about the errors. What happens if an implant fails. What are the alternatives if this treatment plan is not working?

from a tooth abcess that spread to your jawbone and then to your skull what would hte symptoms be? ok thanks!