news: FDA hearing on Avastin recommends no approval

This continues my blog entry from yesterday, day one of the FDA hearing. Click the link for background and further information on this topic.

Although the final decision is not imprinted on rescinding the approval for Avastin® as a treatment for advanced breast cancer, the recommendation by the committee following the completion of the hearing today was that the approval be denied. The basis of the decision was the clinical trials that followed the original accelerated approval based on initial studies failed in two key areas important for evaluating drugs for advanced cancer: extending progression free survival and extending lifespan. Avastin has also proved to have harmful side effects, including increases in blood pressure. Essentially, the studies have suggested that Avastin may have more harmful than helpful effects.

Questions remain.

Will Genentech attempt to conduct further clinical studies?

Will insurance pay for Avastin, prescribed off label, for women who have been receiving Avastin with the apparent therapeutical benefit of no progression?

Will someone else step up to defray the cost of this drug for patients whose options diminish as they exhaust various treatments in keeping their metastases from progressing?

What about those patients whose oncologists have not yet prescribed Avastin but who might have been keeping it in the arsenal until such time that it could be an option? Will insurance cover such an off-label prescription? Will Genentech subsidize?

What drug will step in to occupy that space left by Avastin? I do not see any others at this time since Avastin was the only drug of its kind (it stops the blood flow to cancer tumors) to treat metastatic breast cancer.

Avastin remains an FDA-approved treatment for brain, colon, kidney and lung cancers. Because Avastin will be available for use with those cancers, some oncologists might still prescribe it to patients off-label.

Again, the question arises: who will pay.

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© 2004–2011 Donna Peach. All rights reserved.

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