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Recent Updates for Patients

Avastin in Metastatic Breast Cancer

An FDA hearing was held June 28-29, 2011 about Avastin's use in metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for the disease. The FDA has not announced when this decision will be made. Please see below for more information.

On August 4, 2011, Genentech submitted its post-hearing proposal in support of maintaining accelerated approval of Avastin in combination with paclitaxel for women with previously untreated metastatic breast cancer. The proposal has been submitted to http://www.regulations.gov under Docket no. FDA-2010-N-0621.

On June 29, 2011, the FDA advisory committee recommended withdrawing approval for Avastin for metastatic breast cancer. The final decision on whether Avastin should remain approved for metastatic breast cancer will be made by the FDA Commissioner. The FDA has not announced when this decision will be made.

On May 13, 2011, Genentech submitted a written summary of the arguments the company planned to make and expectations for what its evidence would show at the FDA Hearing. The statement was submitted to http://www.regulations.gov under Docket no. FDA-2010-N-0621.

On May 11, 2011, the Notice of Hearing was posted in the Federal Register. It is also available on http://www.regulations.gov under Docket No. FDA-2010-N-0621.

On April 8, 2011, Genentech submitted a supplement to the April 7 joint statement. The supplement provides the company's perspective on the central questions for the hearing.

On April 7, 2011, Genentech and the FDA's Center for Drug Evaluation and Research (CDER) submitted a joint statement of facts not in dispute and issues that are disputed. The statement was submitted to http://www.regulations.gov under Docket no. FDA-2010-N-0621.

On February 23, 2011, the FDA notified Genentech the agency granted the company a hearing on Avastin's use in metastatic breast cancer. The hearing was held on June 28-29, 2011 in the Great Room on the FDA White Oak Campus in Silver Spring, MD.

On December 16, 2010, the FDA notified Genentech of its proposal to withdraw approval of Avastin® (bevacizumab) for breast cancer.

Below please find answers to some frequently asked questions. This site will be updated as more information becomes available.

  1. What were the FDA's actions on the Avastin metastatic breast cancer indication?
  2. What is an NOOH?
  3. What is the process for a hearing?
  4. What was the result of the FDA hearing on June 28-29, 2011?
  5. When will the FDA make a final decision?
  6. How can I participate in the hearing process?
  7. During these proceedings with the FDA, what is the status of Avastin in metastatic HER2-negative breast cancer?
  8. During this process, what will happen to my insurance coverage for Avastin for metastatic breast cancer?
  9. How does the FDA decision impact Avastin's other approved uses?
  10. How do I learn more about Avastin safety and side effects?



  1. What were the FDA's actions on the Avastin metastatic breast cancer indication?

    On December 16, 2010 the FDA notified Genentech that it is proposing to withdraw approval for Avastin for first-line treatment of metastatic HER2-negative breast cancer in combination with paclitaxel. The agency issued Genentech a Notice of Opportunity for a Hearing (NOOH).


  2. What is an NOOH?

    An NOOH is the mechanism FDA uses to provide a company an opportunity for a hearing on a proposal to withdraw an indication. The NOOH is the beginning of the process.


  3. What is the process for a hearing?

    • On February 23, 2011, the FDA granted the company a hearing.
    • On April 7, 2011, Genentech and the FDA's Center for Drug Evaluation and Research (CDER) submitted a joint statement of facts not in dispute and issues that are disputed.
    • On April 8, 2011, Genentech submitted a supplement to the April 7 joint statement. The supplement provides the company's perspective on the central questions to be presented and resolved at the hearing.
    • On May 11, 2011, the Notice of Hearing was posted in the Federal Register. It is also available on http://www.regulations.gov under Docket No. FDA-2010-N-0621.
    • On May 13, 2011, Genentech submitted a written summary of the arguments the company plans to make and expectations for what its evidence will show at the FDA Hearing.
    • On May 27, 2011, Genentech submitted its list of witnesses who will present at the hearing and a summary of the issues each witness will address.
    • The FDA hearing was held June 28-29, 2011. Transcripts and video recordings of the hearing are available here. The FDA advisory committee recommended withdrawing approval for Avastin for metastatic breast cancer. The final decision on whether Avastin should remain approved for metastatic breast cancer will be made by the FDA Commissioner. The FDA has not announced when this decision will be made.
    • On August 4, 2011, Genentech submitted its post-hearing proposal in support of maintaining accelerated approval of Avastin in combination with paclitaxel for women with previously untreated metastatic breast cancer. Also on August 4, 2011, final comments from the public were accepted and the FDA Docket No. FDA-2010-N-0621 was closed.


  4. What was the result of the FDA hearing on June 28-29, 2011?

    The FDA advisory committee recommended withdrawing approval for Avastin for metastatic breast cancer. The final decision on whether Avastin should remain approved for metastatic breast cancer will be made by the FDA Commissioner. The FDA has not announced when this decision will be made.

    Transcripts and video recordings of the hearing are available here.


  5. When will the FDA make a final decision?

    The final decision on whether Avastin should remain approved for metastatic breast cancer will be made by the FDA Commissioner. The FDA has not announced when this decision will be made.

  6. How can I participate in the hearing process?

    Interested parties were able to submit comments to the FDA docket number 2010-N-0621 until August 4, 2011. The docket was closed after that date.

  7. During these proceedings with the FDA, what is the status of Avastin in metastatic HER2-negative breast cancer?

    Until the FDA Commissioner makes a final decision, Avastin remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer in the United States.

    Full product information, including important safety information is available at: http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf.


  8. During this process, what will happen to my insurance coverage for Avastin for metastatic breast cancer?

    We encourage you to contact Genentech Access Solutions. A specialist can help answer questions you may have about your insurance coverage and discuss other services that may be available to you. Genentech is committed to providing eligible patients with reimbursement and coverage support.

    If you lack insurance coverage, you may be eligible to receive access to free Avastin through the Genentech Access to Care Foundation (GATCF). Eligibility is based on your income level, medical condition and insurance coverage.

    Please call Genentech Access Solutions at (866) 4 ACCESS or visit www.GenentechAccessSolutions.com.


  9. How does the FDA decision impact Avastin's other approved uses?

    This action will not result in any changes to the other approved indications. For more information on Avastin's approved uses in other cancer types please visit www.avastin.com.


  10. How do I learn more about Avastin safety and side effects?

    Patients should discuss any questions about safety or side effects with their doctor.

    For important safety information please visit: http://www.avastin.com/avastin/patient/overview/safety/index.html#/avastin/patient/overview/safety/index.html.

    Please see full Product Information, including Serious Side Effects and important safety information at: http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf.


Resources for Additional Questions

Access Solutions Link to Genentech Access Solutions

Genentech is committed to providing eligible patients with reimbursement and coverage support. Please call (866) 4 ACCESS or visit: GenentechAccessSolutions.com.