Some industry-insiders have suggested the Compassionate Use Program could work for Roche, with Avastin. Now that the FDA has rejected Avastin for breast cancer, breast cancer now becomes a non-approved indication and therefore any investigator wishing to do a compassionate use trial would have to do so under a Treatment IND.
In 1987, the FDA enacted regulations that provided increased access to experimental drugs for patients with life-threatening or seriously-debilitating diseases when no alternative treatment exists. These guideline, commonly called Treatment IND (Investigational New Drug), provide for rapid review of new therapies even when clinical trial results proving efficacy have not been established.
Typically Treatment IND applications are made for drugs that are in Phase III trials; however in rare cases the FDA approves a Treatment IND for a drug that has not yet progressed beyond Phase II. In order to stay compliant with the protocol, the drug developer must continue to collect safety and efficacy data on test subjects in order to better establish a drug's therapeutic benefit to patients.
Additionally, it must continue to make a good faith effort to win final approval from the FDA; if the drug developer stops working on the product, the Treatment IND can be rescinded and patients may lose access to the drug.
The company would have to write the protocol with prettly strict inclusion/exclusion criteria and thus Roche has to ask the question as to whether it's worth it since they can't sell it for this purpose.
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