Hi jtmkjm and Sharon - Here is information from today's New York Times that may be of interest.
Pat
November 18, 2010, 8:38 pm
F.D.A. Approves a Bone Drug for Cancer Patients
By ANDREW POLLACK
The Food and Drug Administration on Thursday approved the use of Amgen’s bone drug denosumab as a treatment for cancer patients whose disease has spread to their bones.
The drug, which will be called Xgeva, does not treat the cancer itself. Rather, it helps prevent fractures, spinal cord compression or other bone problems that can arise as cancers weaken the bones.
Denosumab, which is considered crucial to Amgen’s future, was approved in June as a treatment for osteoporosis in post-menopausal women. It is sold for that purpose under the name Prolia. Sales so far have been slow.
But the use for cancer patients might be more lucrative for Amgen because cancer patients will use 12 times as much of the drug a year than osteoporosis patients do. Sales could easily surpass $1 billion a year, some analysts estimate.
The wholesale price of Xgeva will be $1,650 for an injection given every four weeks, the company said.
Amgen needs strong sales of denosumab because growth is slowing for its now mature portfolio of other products. And sales of its anemia drug Aranesp have fallen over the last few years because of safety concerns.
Bone metastases are quite common, particularly for advanced prostate, breast and lung cancer. For patients with advanced prostate cancer, bone metastases are the dominant cause of death and symptoms, said Dr. Matthew R. Smith, a prostate cancer specialist at the Massachusetts General Hospital Cancer Center.
Amgen tested Xgeva directly against Novartis’s Zometa, which is already approved to prevent bone problems in cancer patients. Xgeva proved superior in prostate and breast cancer in reducing the risk of fractures, spinal cord compression or the need for surgery or radiation treatment for bone problems.
For other solid tumors Xgeva was roughly equivalent to Zometa. But Xgeva did not work well in multiple myeloma, a cancer of the bone marrow, so it is not approved for patients with that cancer or other blood and lymphatic cancers.
Amgen, the world’s largest biotechnology company, is also testing whether denosumab could actually prevent the spread of cancer to the bone in the first place. There is no drug approved for that purpose. Results of that trial are expected before the end of this year.
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Hi jtmkjm and Sharon - Here is information from today's New York Times that may be of interest.
Pat
November 18, 2010, 8:38 pm
F.D.A. Approves a Bone Drug for Cancer Patients
By ANDREW POLLACK
The Food and Drug Administration on Thursday approved the use of Amgen’s bone drug denosumab as a treatment for cancer patients whose disease has spread to their bones.
The drug, which will be called Xgeva, does not treat the cancer itself. Rather, it helps prevent fractures, spinal cord compression or other bone problems that can arise as cancers weaken the bones.
Denosumab, which is considered crucial to Amgen’s future, was approved in June as a treatment for osteoporosis in post-menopausal women. It is sold for that purpose under the name Prolia. Sales so far have been slow.
But the use for cancer patients might be more lucrative for Amgen because cancer patients will use 12 times as much of the drug a year than osteoporosis patients do. Sales could easily surpass $1 billion a year, some analysts estimate.
The wholesale price of Xgeva will be $1,650 for an injection given every four weeks, the company said.
Amgen needs strong sales of denosumab because growth is slowing for its now mature portfolio of other products. And sales of its anemia drug Aranesp have fallen over the last few years because of safety concerns.
Bone metastases are quite common, particularly for advanced prostate, breast and lung cancer. For patients with advanced prostate cancer, bone metastases are the dominant cause of death and symptoms, said Dr. Matthew R. Smith, a prostate cancer specialist at the Massachusetts General Hospital Cancer Center.
Amgen tested Xgeva directly against Novartis’s Zometa, which is already approved to prevent bone problems in cancer patients. Xgeva proved superior in prostate and breast cancer in reducing the risk of fractures, spinal cord compression or the need for surgery or radiation treatment for bone problems.
For other solid tumors Xgeva was roughly equivalent to Zometa. But Xgeva did not work well in multiple myeloma, a cancer of the bone marrow, so it is not approved for patients with that cancer or other blood and lymphatic cancers.
November 18, 2010 - 8:10pmAmgen, the world’s largest biotechnology company, is also testing whether denosumab could actually prevent the spread of cancer to the bone in the first place. There is no drug approved for that purpose. Results of that trial are expected before the end of this year.
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