WASHINGTON — Federal health scientists said Friday that follow-up studies of a Roche breast-cancer drug showed that it failed to extend patient lives, opening the door for the drug to be potentially withdrawn for use in treating that disease.
The Food and Drug Administration approved Roche's blockbuster Avastin in 2008 based on a trial showing it slowed growth of tumors caused by breast cancer. The decision was controversial because drugs for cancer patients who have never been treated before must usually show evidence they extend lives.
Avastin's so-called "accelerated approval" was based on the condition that later studies would show a survival benefit.
But in briefing documents posted online, FDA reviewers said two follow-up studies recently submitted by Roche failed to show that Avastin significantly extended lives compared to chemotherapy alone.
Additionally, the FDA said that in follow-up studies the drug did not slow tumor growth to the same degree as in earlier studies.
Patients taking Avastin showed significantly more side effects, including high blood pressure, fatigue and abnormal white blood-cell levels.
On Tuesday the FDA will ask a panel of outside cancer experts to review the evidence on Avastin. The panel's recommendations are not binding, but the FDA usually follows their guidance.
Saturday, July 17, 2010
FDA: Breast-cancer drug Avastin does not extend lives | Seattle Times Newspaper
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2 comments:
Actual results in patients count and theory doesn't matter as much as the evidence that it does what we want it to do. It would be more advantegeous to sort out what's the best profile in terms of which patients benefit from this drug.
Some scientists are not sure whether Avastin or any other anti-angiogenic agents are working primarily by pruning new blood vessels, increasing the delivery of another anti-cancer therapy, or potentially another mechanism.
Clinical oncologists involved with functional tumor cell profiling analysis, can actually examine this. They have a method for testing anti-angiogenic/anti-microvascular agents, such as Avastin and testing for synergy between different anti-microvascular agents on an individual patient, individual tumor basis. Avastin appears to better deliver the effects of other classes of drugs.
Avastin facilitates vascular access of cytotoxics to tumors. It will take combination antivascular therapy to make a big difference, but this is definitely coming and it's the most promising thing on the near term therapeutic horizon.
As for Avastin's side effects. Evidence in the Journal of Clinical Oncology shows that many of the highly expensive targeted drugs like Avastin may be just as effective and produce fewer side effects if taken over shorter periods and in lower doses. Avastin is one example. The dose being used is 15 milligrams per kilogram of body weight, despite research showing it may work with 3 milligrams per kilogram.
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