27 May 2010 . In Europe, Avastin is currently licensed for first-line treatment of patients with metastatic breast cancer in combination with paclitaxel .

27 Jul 2010 . On July 20, the Oncologic Drugs Advisory Committee (ODAC) of the FDA's Center . plus bevacizumab for locally recurrent or metastatic breast cancer. . “Because treatment with Avastin is associated with considerable .

30 Jul 2010 . TESTIMONY TO ODAC. APPLICATION FOR APPROVAL OF AVASTIN. JULY 20, 2010. My name is Roberta Gelb and I am a breast cancer survivor and a .

A final decision on Avastin's use in breast cancer is expected this fall .

18 Aug 2010 . The FDA allowed the use of Avastin for metastatic breast cancer in 2008 . ODAC's advice is not binding, and the FDA will deliver its final .

10 Sep 2010 . “I give the majority of my advanced breast cancer patients bevacizumab . treated with Avastin for breast cancer will continue to have access to . according to the ODAC, which emphasized the lack of a survival benefit .

20 Jul 2010 . Today I will be out of the office at client meetings, but many of you will be wondering what will happen at the FDA ODAC briefing meeting, .

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20 Jul 2010 . The FDA's Oncologic Drugs Advisory Committee has voted 12-1 to remove bevacizumab's indication as a first-line therapy for metastatic .

Genentech disappointed with FDA ODAC's recommendation against Avastin . . Gene amplification could guide treatment for high-risk breast cancerA new study .

7 Dec 2007 . The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 5–4 recommending that the data in Genentech's supplemental biologics license .

There was only one breast cancer oncologist on the ODAC panel. EXCERPT FROM THE ESTEEMED PANEL: Since PFS (progression free survival) is the endpoint being .

by HJ Burstein - 2010

1 Jan 2008 . Major policy issue lies behind ODAC's Avastin decision . Judging multigene tests for breast cancer recurrence before the results are in .

10 Aug 2010 . The story surrounding the FDA's process for the final approval of Avastin (bevacizumab) for advanced breast cancer raises many questions .

21 Jul 2010 . News of the ODAC's recommendation caused Roche's shares to slide 4.2% . Avastin was first approved for the treatment of breast cancer by .

18 Feb 2008 . What's the pulse on ODAC & Avastin? Genentech. . What are the vibes you are getting for the Avastin breast cancer meeting coming up. .

6 Aug 2010 . ODAC's discussion of stripping Avastin's breast cancer indication is important because it constitutes the first ever public discussion of .

21 Jul 2010 . FDA-ODAC Votes To Remove Avastin's Breast Cancer Indication Bevacizumab (Avastin, Genentech) is likely to lose its breast cancer indication, .

Social comments for "Time for FDA and ODAC to decide on Avastin in breast cancer" See what people are saying on blogs, Twitter, Digg, FriendFeed and many .

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. FDA revoke the approval of bevacizumab (Avastin®) as a first-line .

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by MJ Fromer - 2008

The effectiveness of Avastin in advanced breast cancer is based on an .

20 Jul 2010 . Joanne Mortimer, MD, a member of ODAC, who voted to approve bevacizumab in advanced breast cancer in December 2007 based on the E2100 study, .

20 Jul 2010 . The effectiveness of Avastin in advanced breast cancer is based on an improvement . The ODAC reviewed data from all three studies (E2100, .

19 posts - 9 authors - Last post: 24 JulHe summarized the outcome of the meeting as follows: "ODAC members . . The FDA in 2008 approved Avastin for breast cancer patients based on .

by M Allison

14 posts - 11 authors - Last post: 21 JulHe summarized the outcome of the meeting as follows: "ODAC members found .

On July 20, the Oncologic Drugs Advisory Committee 1 (ODAC) of the FDA's .

18 Aug 2010 . Few of the Avastin panelists had any first-hand clinical experience with metastatic breast cancer. Six of the 13 members sat on the ODAC .

Time for FDA and ODAC to decide on Avastin in breast cancer .

On July 20th, ODAC will revisit the approval of bevacizumab based on PFS .

Time for FDA and ODAC to decide on Avastin in breast cancer. Newsweek: Why the FDA may reverse course on Avastin. "FDA May Revoke Avastin For Advanced .

by HJ Burstein - 2010

Avastin, ODAC, and the FDA: Are We Drafting the Right Players? .

Today I will be out of the office at client meetings, but many of you will be wondering what will happen at the FDA ODAC briefing meeting, which will be .

Few of the Avastin panelists had any first-hand clinical experience with metastatic breast cancer. Six of the 13 members sat on the ODAC panel that judged .

By Trista Morrison Despite a negative recommendation from the Oncologic Drugs Advisory Committee, Genentech Inc.'s Avastin (bevacizumab) gained accelerated .

20 Jul 2010 . These new ODAC recommendations are only about using Avastin to treat metastatic breast cancer. Avastin is approved by the FDA to treat .

4 Oct 2010 . Breast Cancer Action supports this decision by ODAC because it . Avastin does not meet any of these criteria in the breast cancer context. .

The Oncologic Drugs Advisory Committee (ODAC) of the FDA has recommended .

25 Feb 2008 . Despite a negative recommendation from the Oncologic Drugs Advisory Committee, Genentech Inc. 's Avastin (bevacizumab) gained accelerated .

5 Oct 2010 . Breast Cancer Action supports this decision by ODAC because it puts . The Avastin approval process has been going on for several years. .

11 Oct 2010 . ODAC recommended revoking the accelerated approval by a vote of 12-1. . Breast-cancer patients all over the world are using Avastin. .

ODAC Denies Recommendation for Avastin® Approval for Breast Cancer. The United States Food and Drug Administration's (FDA's) Oncology Drugs Advisory .

It is important that the breast cancer community rest assured that ODAC is an independent, unbiased panel of experts in oncology whose mission is to provide .

21 Jul 2010 . He noted that the FDA decided not to accept the ODAC's December 2007 5-to-4 vote against approval of Avastin in breast cancer. .

by NAVW No