[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11554-11555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4424]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0621]


Final Decision on Withdrawal of Breast Cancer Indication for 
AVASTIN (Bevacizumab) Following Public Hearing; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the final decision withdrawing approval of the breast 
cancer indication for AVASTIN (Bevacizumab). The Commissioner of Food 
and Drugs (the Commissioner) issued the decision following a June 2011 
public hearing on a proposal to withdraw the approval.

DATES: Withdrawal of AVASTIN's breast cancer indication was effective 
November 18, 2011.

ADDRESSES: Submit written requests for single copies of the decision to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002. The final decision, hearing 
transcript, and other documents may be seen in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1601, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the decision and related documents.

FOR FURTHER INFORMATION CONTACT: Sharon Sickafuse, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2320.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 22, 2008, FDA's Center for Drug Evaluation and Research 
(CDER) approved a supplemental biologics license application (sBLA 
125085/91) submitted by Genentech, Inc. (Genentech), for the use of 
AVASTIN in combination with paclitaxel for patients who have not 
received chemotherapy for treatment of HER2-negative metastatic breast 
cancer (MBC). This approval was issued under the Agency's accelerated 
approval regulations for biological products, 21 CFR part 601, subpart 
E. Consistent with those regulations, the approval was

[[Page 11555]]

subject to the requirement that the product be studied further to 
verify and describe its clinical benefit. On November 16, 2009, 
Genentech submitted the results of two clinical trials intended to 
satisfy this requirement. CDER determined that these trials failed to 
verify AVASTIN's clinical benefit in the treatment of MBC and on 
December 16, 2010, issued a notice of opportunity for a hearing to 
Genentech proposing to withdraw approval of AVASTIN's MBC indication. 
Genentech submitted a hearing request dated December 23, 2010, followed 
by a submission of data and information on which it would rely at a 
hearing. The Agency granted Genentech's hearing request and published a 
notice of hearing on May 11, 2011 (76 FR 27332). The hearing was held 
on June 28 and 29, 2011. Following the hearing, on November 18, 2011, 
the Commissioner issued a final decision withdrawing approval of 
AVASTIN's MBC indication.

II. Electronic Access

    Persons with access to the Internet may obtain the final decision 
at http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf. The 
final decision, a transcript of the hearing, and other documents 
pertaining to the withdrawal of Avastin's MBC indication are available 
at http://www.regulations.gov under the docket number found in brackets 
in the heading of this document.

    Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4424 Filed 2-24-12; 8:45 am]
BILLING CODE 4160-01-P