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Thread: FDA advisory committee votes that FDA withdraw its approval of Avastin

  1. #1

    Post FDA advisory committee votes that FDA withdraw its approval of Avastin

    On Tuesday, July 20th, the Oncologic Drugs Advisory Committee recommended in a 12-1 vote that the FDA withdraw its approval of Avastin as a treatment for advanced breast cancer.

    In 2008, Avastin was given accelerated and conditional approval by the FDA for metastatic breast cancer treatment. Its manufacturer, Genentech, a subsidiary of Roche, was then required to do further studies to confirm the benefit of the drug.

    The two new studies sponsored by Roche showed Avastin did not meet the standards that BCA has long maintained for any new drug approved for treatment. It is believed that a drug should meet at least one of the following standards: 1) extend the life of the patient, i.e., improve overall survival, and/or 2) improve the patient's quality of life, and/or 3) cost less than therapies already available.

    Roche agreed with the committee's recommendation, and were saddened that after all this time there's still no good option to offer patients when current treatments have failed.

    However, 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.

    Many doctors have been using Avastin "off-label" against a variety of cancer types. An estimated 60 percent of anti-cancer drugs are used off-label. It has been very routine and well-accepted practice to prescribe drugs in cancer types and disease stages outside of those in which the drugs originally received FDA approval. Generally, insurance companies have paid for drugs used outside of FDA-approved settings because the treating physician finds their use in those instances to be medically necessary. That's why I would personally want to have Avastin pre-tested against a tumor first to see if it was beneficial.

    If a pre-test (functional tumor cell profiling) can establish that Avastin would be beneficial, a treating physician could use that to find its use to be medically necessary and pressure insurance companies to pay for the drugs outside of FDA-approved settings.
    Gregory D. Pawelski

  2. #2

    Anti-vascular effects of Avastin have been studied in real-time

    Direct anti-tumor and anti-vascular effects were studied of Avastin in fresh biopsy specimens of breast cancer and presented at the American Society of Clinical Oncology Breast Cancer Symposium on September 5, 2008.

    Drugs like Avastin had striking anti-microvascular effects but minimal anti-tumor effects. Anti-microvascular additivity was observed between Avastin and other drugs on an individual basis.

    Conclusions of the study had shown that Avastin + Tykerb may be the first clinically-exploitable antivascular drug combination. High dose, intermittent 'bolus' schedules of Tykerb to coincide with Avastin administration may be clinically advantageous, even in HER2-negative tumors.

    The system utilized for the study was a functional profiling assay, which may be used to individualize antivascular therapy. It can be adapted for simple, inexpensive and sensitive/specific detection of tissue and circulating microvascular cells in a variety of neoplastic and non-neoplastic conditions, for drug development, and individualized cancer treatment.

    It can accurately sort drugs into categories of above average probability of providing clinical benefit on one hand and below average probability of providing clinical benefit on the other hand, based both on tumor response and patient survival.
    Gregory D. Pawelski


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