Avid Bioservices Inc (CDMO)

[freethemice]

Thurly, here is a more recent (2011 vs 2004), but similar article, also in the JNCI.
Accelerated Approval of Oncology Products: The Food and Drug Administration Experience
http://jnci.oxfordjournals.org/content/103/8/636.abstract

Note the sentences in bold below. Does this mean that if AA were to be approved for Bavi in second-line NSCLC that the confirmatory trial could be done in first-line patients? Then Bavi could get approved for both first-line and second-line based on the one phase 3 trial??
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Treatment of cancer patients is directed at prolonging their life (improved survival) and/or giving them a better life. All other endpoints used in cancer clinical trials must be surrogates for one or both of these. Surrogate endpoints to predict improved survival or a better quality of life or may either be established to do so or be reasonably likely to do so.
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The purpose of the accelerated approval regulation is to make drugs more rapidly available to cancer patients. The FDA has taken two policy initiatives to optimize the accelerated approval process and maximize the benefits of earlier availability of drugs to cancer patients. First, the accelerated approval regulations require that drugs that are granted accelerated approval be better than “available therapy.” This requirement greatly limits the number of drugs that are granted accelerated approval, especially for refractory indications, because once a drug is granted accelerated approval for an indication, that drug would block future accelerated approvals for that indication because it would be the “available
therapy.” The FDA policy initiative that removes this roadblock specifies that a drug that is granted accelerated approval cannot be considered “available therapy” because clinical benefit has not been confirmed. Thus, cancer patients need not be nonresponsive to drugs granted accelerated approval to be considered nonresponsive to “available therapy.” Second, postapproval trials to confirm clinical benefit for accelerated approvals need not be conducted in the same population as the trial that was considered for the accelerated approval and may be conducted in patients with a less advanced stage of the same cancer type. Otherwise, it may be difficult to accrue patients to a randomized confirmatory trial after the drug has already been shown to be reasonably likely to be better than available therapy.
The FDA considers “better than available therapy” to mean better efficacy. Although a drug with equal efficacy and less toxicity could possibly qualify as better than available therapy, the difference in toxicity must be substantial. Such a situation has not yet arisen.
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