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Genentech fires back at FDA

FDA doesn’t want to give the thumbs up for Avastin’s use as a first-line therapy for breast cancer, and Genentech has a few things to say about that:
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GENENTECH SUBMITS RESPONSE TO FDA’S NOTICE OF OPPORTUNITY FOR A HEARING ON PROPOSAL TO WITHDRAW APPROVAL OF METASTATIC BREAST CANCER INDICATION FOR AVASTIN

SOUTH SAN FRANCISCO, Calif. (January 18)—Genentech Inc., a member of the Roche Group, today submitted its response to the U.S. Food and Drug Administration’s (FDA) Notice of Opportunity for a Hearing (“NOOH”) on the Agency’s proposal to withdraw approval of the metastatic breast cancer (mBC) indication for Avastin (bevacizumab). Genentech has submitted the response and supporting documentation electronically to http://www.regulations.gov under Docket No. FDA-2010-N-0621. Regulations.gov controls the timing of the documents being made public on its website. Click here to view the response on Genentech’s website.

The response explains Genentech’s right to a hearing to allow full and fair discussion of the issues in a public forum, and sets forth the data, analyses and information on which Genentech intends to rely at a hearing to demonstrate why Avastin should remain an FDA-approved option for women in the United States with HER2-negative mBC.

Genentech believes women with mBC in the United States are entitled to Avastin as an FDA-approved choice and that accelerated approval of Avastin in combination with paclitaxel should be maintained. The company has proposed conducting a new confirmatory trial of Avastin plus paclitaxel, the chemotherapy combined with Avastin in the study that led to accelerated approval, in HER2-negative mBC to the FDA. The trial would have a biomarker component with the intent of identifying people who may be more likely to derive a greater benefit from Avastin.

At this time and until the conclusion of the proceedings with the FDA, Avastin remains approved for use in combination with paclitaxel for the first-line treatment of HER2-negative mBC in the United States. The effectiveness of Avastin in HER2-negative mBC is based on an improvement in progression-free survival in the E2100 study. There are no available data showing that Avastin improves disease-related symptoms or survival in HER2-negative mBC. Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease.

Doctors with questions about the use of Avastin for mBC can call Genentech’s Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage can call Genentech’s Access Solutions Group at (866) 4 ACCESS.

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Also worth noting is a story from the San Francisco Business Times:

Genentech Inc. responded to the Food and Drug Administration, saying it wants to present evidence and make arguments against the FDA’s plan to withdraw approval for use of Avastin as a breast cancer treatment.

The FDA said Dec. 16 it planned to withdraw its OK for Avastin as a first-line treatment for metastatic HER2-negative breast cancer combined with paclitaxel. South San Francisco-based Genentech asked the FDA for a hearing on Dec. 23. Today’s submission includes all the evidence and data that Genentech plans to rely on in its arguments at the hearing, for which no date has yet been set.

Genentech, which is owned by Swiss giant F. Hoffman-La Roche Ltd., told the FDA that “a hearing is particularly warranted” because the drug has already been used for this treatment (the FDA approved it in early 2008) and because European regulators, who reviewed the same data, supported the use of Avastin in breast cancer.

“Since this approval, thousands of women with MBC have been treated with Avastin in the United States,” Genentech said.

For its part, the FDA looked at Avastin when it was later tested in combination with two other types of chemotherapy than paclitaxel. Avastin didn’t do as well in those tests as it did with paclitaxel. Genentech disagrees with the FDA’s interpretation of that data and those two tests.

“We look forward to the opportunity to present our views more fully on these important issues,” said Michelle Rohrer, Genentech’s vice president of regulatory affairs, in a letter to the FDA.

Until talks with the FDA are finished, the drug is still being used to treat breast cancer along with paclitaxel. Avastin isn’t used by patients who’ve already had chemotherapy.

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January 20, 2011 - Posted by | Corporate, Government

2 Comments »

  1. My significant other has stage four breast cancer. He has had 12 treatments of avastin and after 9 treatments the CT scan showed a 50% reduction of the tumor. With this concrete evidence, I strongly urge the FDA to continue the approval of avastin for breast cancer.

    Comment by Marie Moore | February 5, 2011 | Reply

  2. Thanks for the input, Marie. It’s a challenging situation as most of us watch such things from the sidelines and scratch our heads, wondering what’s at work. Is the FDA trying to be overcautious to be on the safe side? Do they want to rein in prescriptions (and thus healthcare spending) b/c the therapy is not seen as clearly beneficial enough? Are they just not “getting it”…or is it some other reason entirely.

    I recognize that the FDA can’t please all parties, nor should it, but I do worry…often…that it fails to strike the right balance between patient, costs, safety and other factors.

    Comment by Jeffrey Bouley, ddn Managing Editor | February 5, 2011 | Reply


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