Nexavar fails late-stage lung cancer trial
“While we are disappointed in this outcome, Bayer and Onyx remain committed to our comprehensive pan-tumor clinical trial program for Nexavar”
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals Inc. of Emeryville said a Phase III study of their cancer drug Nexavar in non-small cell lung cancer patients was stopped after failing to improve ... via San Francisco Business Times
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Since: Dec 05
#1 Feb 23, 2008
"Nexavar is already approved in more than 30 countries for liver cancer and in more than 60 countries for the treatment of patients with advanced kidney cancer. But an additional indication for lung cancer would push it past the $1 billion sales mark."
The FDA easily approves a drug by indication(why is it that youre going to take the drug). A drug company presents a drug and wants approval for two or three different indications. One may be really insignificant, affecting a very small number of people (lung cancer). The major indication might affect millions of people (liver and/or kidney cancer).
The drug doesnt necessarily show efficacy for the lung cancer indication, but theyre able to get it approved for the liver and/or kidney cancer indication, while the FDA and the drug company both know the drug is going to be used for that all indications.
Its going to be used off-label" for lung cancer. The FDA should be intervening, but they dont. The the FDA says that they dont regulate the off-label use of drugs, and allows it to happen, and the off-label use of the drug becomes a public health threat. Nexavar, in combination with standard therapy, kills more patients than standard therapy alone.
Combination chemotherapy has not always produced greater degrees of clinical benefit than single agent therapy, as this clinical trial illustrates. When two or more drugs are given, there is a greater probability that at least one of the drugs will be active. There is then the potential for true synergery, where the whole is greater than the sum of the parts.
But most drug combinations are only additive or at most, minimally synergistc. However, some newer combinations show greater degrees of synergy, although apparently not in this study. True synergy is rather uncommon in most adult solid tumors. Most drug combinations in diseases are merely additive, where the whole equals the sum of its parts, and not synergistic. In hematologic neoplasms (leukemia, lymphoma, multiple myeloma), true synergy is very common.
In cases like this study, where drugs are only additive and not synergistic, nothing is learned by testing the drugs in combination compared to what is learned by testing them separately. Therefore, drugs in combination are only tested in cases where there is the realistic possiblitiy of seeing true synergy.
The best combinations are those in which there is true synergy and in which the toxicities of the drugs in the combination are non-overlapping, so that full doses of each drug may be given safely.
The era of empiric, aggressive, multi-agent cytotoxic chemotherapy for first-line/recurrent/refractor y adult solid tumors should come to an end.
More emphasis should be put on matching treatment to patient, through the use of individualized genetic and cellular pre-testing, having more respect for minimal partial response or stable disease, when it can be achieved through use of the least toxic and mutagenic drug regimens, and reserve the use of higher dose therapy or aggressive combination chemotherapy to those patients with tumor biologies most amenable to attack and destroy by these aggressive treatments.
#2 Apr 16, 2008
im not sure how to take this article, my husabnd is to start his treatmnet. Has liver cancer and a tumor from the liver to the lung? should i proceed with this treatmnt of wait, now i'm more comfued then ever and my gut is dont give him any chemo, this is after colon cancer, xeloda great drug, no colon cancer since 2004!! but the liver may have caused this tumor in the lung, so, please someone give me somemore feed back email is listed, [email protected]
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