FDA Withdraws Approval of Breast Cancer Indication from Avastin Label

Nov 28, 2011   
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On November 18, 2011, the U.S. Food and Drug Administration (FDA) announced its decision to revoke the approval of the breast cancer indication for Avastin. Because Avastin will still be approved for its other uses, including the treatment of brain, kidney, lung and colon cancer, the drug will remain on the market despite this recent decision. The FDA initially approved Avastin for the treatment of breast cancer based on evidence showing that the drug may restrict tumor growth. However, according to the FDAs decision to revoke its approval, further clinical data has shown that the drug may only marginally limit tumor growth.

Found here, the decision of FDA Commissioner Margaret Hamburg details the procedures whereby Avastin gained approval for this indication and the reasoning for its recent revocation. In 2008, FDAs Center for Drug Evaluation and Research (CDER) approved Avastin for the treatment of breast cancer through the Agencys accelerated approval process. Set forth in 21 C.F.R. § 601.40-46, this process allows biological products to secure approval for the treatment of life-threatening diseases upon showing some evidence that the drug may provide clinical benefit. However, as a condition to accelerated approval, manufacturers are required to continue clinical testing and report their findings to the FDA. Under 21 C.F.R. § 601.43(a), the FDA may withdraw approval where the required postmarketing testing “fails to verify clinical benefit,” where applicants are noncompliant in performing such testing, and where applicants otherwise fail to comply with other postmarketing restrictions.

Because FDA determined that further studies did not verify the level of clinical benefit that prompted the original approval, CDER proposed its withdrawal of approval for this indication in December 2010. Thereafter Avastins sponsor, Genentech, Inc., was afforded an opportunity to show the FDA why this approval should not be withdrawn. This opportunity for hearing is mandated by 21 C.F.R. § 601.43(b). Genentechs arguments were unavailing, and the FDA ultimately withdrew its approval for the breast cancer indication.

While this indication is no longer permitted in product labeling, doctors may still prescribe the drug for use in the treatment of breast cancer. Although manufacturers are limited to marketing drugs for the indications approved in product labeling, FDA regulations do not prevent doctors from prescribing drugs for other uses, a practice known as “off-label” use. Thus, despite the revocation of this indication in product labeling, Avastin may continue to be used to treat breast cancer.

For more information regarding the FDAs drug approval process, please contact us at contact@fidjlaw.com.