Re: (Nice) says that Velcade, the only licensed drug for people with multiple myeloma who have relapsed, should be given only to those taking part in clinical trials.
- From: J <macyinno@xxxxxxxxxx>
- Date: Wed, 26 Jul 2006 06:03:03 -0400
J wrote:
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2006/07/26/ncanc26.xml
Cancer drug ban a death sentence, say sufferers
By Celia Hall and Andy Lines
(Filed: 26/07/2006)
A drug that improves and prolongs the lives of thousands of cancer
patients should not be available on the health service, a Government
advisory group unexpectedly recommended. Patients described the decision
yesterday as a death sentence.
The draft recommendation by the National Institute for Clinical Excellence
(Nice) says that Velcade, the only licensed drug for people with multiple
myeloma who have relapsed, should be given only to those taking part in
clinical trials.
Velcade, also called bortezomib, is recommended for use in Scotland, Wales
and Northern Ireland and in countries across Europe and the rest of the
world. It costs up to £18,000 per patient and extends life by 18 to 24
months on average.
The International Myeloma Foundation said that only about 4,000 English
patients a year would be prescribed the treatment and many would not need
the full course, reducing the cost.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00905.html
May 13, 2003
FDA Approves Velcade for Multiple Myeloma Treatment
The Food and Drug Administration (FDA) today announced the approval of Velcade
(bortezomib) injection, a new treatment for multiple myeloma, a cancer of the
bone marrow. FDA reviewed the application for this drug in less than four
months. Velcade is the first in a new class of anticancer agents known as
proteasome inhibitors.
Velcade was approved under the accelerated approval program. The program helps
make promising products for serious or life threatening diseases available
earlier in the development process by allowing approval to be based on a
promising effect of the drug, such as tumor shrinkage, before there is actual
evidence of improved survival or other clinical benefit. The drug?s commercial
sponsor worked closely with FDA to define the studies that would be conducted.
"As a result of close collaboration among the company, The National Cancer
Institute, and FDA in the development and review of the drug, FDA was able to
make this novel therapy available sooner to help many thousands of patients
suffering from multiple myeloma." said FDA Commissioner Mark B. McClellan,
M.D., Ph.D. "The approval of Velcade illustrates FDA?s commitment to providing
patients with access to safe and effective drugs as quickly as possible."
Velcade is indicated for patients whose disease has relapsed after two prior
treatments and who have demonstrated resistance to their last treatment.
FDA evaluated the safety and efficacy of Velcade based on a study of 202
patients who had received at least two prior therapies and demonstrated disease
progression on their most recent therapy. Altogether, out of 188 patients
evaluated for response, twenty eight percent showed a response to Velcade. The
response lasted a median time of one year. Another trial in 54 patients with
relapsed multiple myeloma showed similar responses.
As of yet there are no controlled trials of Velcade demonstrating clinical
benefit, such as improvement in survival. To address this issue, Velcade?s
developer will perform additional studies after approval. These will include
the completion of an on-going study and an additional study comparing Velcade
to standard therapy.
"The drug shows a significant effect on patients with multiple myeloma that
have not responded to other treatments ? a response that is likely to result in
significant clinical benefit," said Dr. McClellan. "As with other treatments
approved under our accelerated approval process, further studies are necessary
for clarifying Velcade?s clinical benefits."
The most commonly reported adverse events reported in clinical trials include
nausea, fatigue, diarrhea, constipation, headache, decreased appetite,
decreased platelets and red cells in the blood, fever, vomiting, and peripheral
neuropathy (numbness and tingling, and occasionally pain in the extremities.)
Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin?s
lymphoma. It is a cancer of the plasma cell, an important part of the immune
system that produces antibodies to help fight infection and disease. There are
approximately 45,000 people in the United States living with multiple myeloma
and an estimated 14,600 new cases of multiple myeloma are diagnosed each year.
.
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