FAMEDs Newsletter #7


June 23, 2011


We want to issue special thanks for Andrew Katz of New York City for composing and performing the Avastin Fight Song. It is on our home page and on YouTube. It has also received favorable press mention. Andrew will also hopefully be with us at the protest in Silver Spring, Maryland on June 28th to lead our musical efforts.


Click Here to see the YouTube video.

With less than a week to go until the hearing, media attention has picked up! FAMEDS has been on a steady stream of radio and mentioned quite frequently in the press. Some recent activity is shared below:




Decision on Avastin will have broad impact; Genentech wants to extend approval


It is crucial that the Avastin story be told and the best people to tell the world about the importance of Avastin are the patients themselves and their immediate families. If you can make a home video (nothing too professional) that we can post or a photo with a letter, we would love to hear from you! Please contact us at terry.kalley@fameds.org or call us at 248.761.8215. Please all also visit our home page where we have posted the stories of several of these women and their families.


We are still looking for at least another 20+ people to join our peaceful protest outside the FDA on June 28 in Silver Spring, Maryland. The protest will run from 7a.m. until 8 a.m. so that we can attend the hearing when it starts around 8 a.m.

If you intend to join us, please sign up at fameds.org/protest. We need to know who will be there so that we can provide sufficient protest T-shirts (pink, of course), create sufficient banners, etc. We do encourage all cancer patients, family members, and friends who plan to attend the protest and/or the hearing to wear pink on the day of the hearing. We want the panel that will make the life and death decision on our Avastin women to know that they are real and our support for them is in that room!

You can also call protest organizer Ted at 248.925.7592 for any protest questions you might have.

We shall hold our last organizing meeting for the protest at 8 pm EST on Thursday, June 23 and it will run a maximum of 30 minutes. For those that wish to participate, here are the call-in details:

Conference Dial-in Number: (605) 475-4000
Participant Access Code: 586521#


Below is an article from the publication Pink Sheet Daily. It explains some of the issues related to the composition of the advisory panel that will hear the evidence at the hearing and vote on the issues. The FDA has essentially called back the same "jury" to hear the appeal as rendered a verdict at the lower court. When asked why the FDA could not find another set of experts to sit at the hearing, the FDA responded that it did not think that it could find another 13 individuals without bias. FAMEDS believes that the panel is inherently biased because they have already shown and voted their opinions publicly. It is too great a burden to expect these panelists to reverse their decisions publicly on such an important matter. What the FDA has done is to pack the court with safe, known votes. FAMEDS therefore believes that the hearing is a Kangaroo court incapable of rendering an unbiased verdict.

FAMEDS disagrees with the Pink Sheets in one respect: while the drug Avastin is nominally on trial, it is really the women who take it that are on trial. A drug is not harmed by the outcome – it is the patients who rely on it for their lives.

Avastin On Trial: The Jurors
Pink Sheet Daily
By Sue Sutter
June 20, 2011

FDA's Oncologic Drugs Advisory Committee will serve as the figurative "jury" at the June 28-29 hearing on the Center for Drug Evaluation and Research's proposal to withdraw Avastin's accelerated approval for metastatic breast cancer.

ODAC, which has twice reviewed and voted against the breast cancer claim for bevacizumab, is serving as the hearing panel over the strong objections of Genentech. The sponsor argued the committee lacks the appropriate breast cancer expertise and individual panelists have already expressed clear opinions about the data, thereby compromising their objectivity. FDA hearing official Karen Midthun has said ODAC will not be supplemented with other consultants or temporary voting members for the hearing, and in a March 29 letter to Genentech she noted that new members would join the panel before the hearing.

Four new voting members were added in May, filling all vacancies on the panel. The committee now has 13 voting panelists, and one non-voting industry representative.

FDA has not yet released the list of ODAC members who will participate in the hearing. Nevertheless, two of the new members – Deborah Armstrong, Johns Hopkins University, and Antoinette Wozniak, Wayne State University – confirmed in response to inquiries from "The Pink Sheet" that they would not be taking part in the Avastin hearing. Armstrong said she participated in one of the trials under discussion and has been recused.

In addition, two of the pre-existing ODAC members – Margaret Tempero, University of California-San Francisco, and Willam Kelly, Thomas Jefferson University – did not participate in the committee's July 2010 review of Avastin's MBC claim. Both have served as investigators in studies of bevacizumab for other types of cancers, which could result in their recusal from the hearing on MBC. Below are the names, backgrounds, ODAC terms and Avastin-related voting histories of the 12 current ODAC members who have either confirmed that they expect to sit at the hearing or did not respond when asked about their participation. For the two newest members, information about previous FDA advisory committee experience is also included. The information was gathered from the panelists' curricula vitae, other FDA documents, "The Pink Sheet" archives and Elsevier Business Intelligence's new Inteleos Advisory Committee One database. Information about previous collaborations between ODAC members and the witnesses that CDER and Genentech intend to proffer at the hearing is also included. In its written summary of evidence for the hearing, CDER specifically cited the expertise of four ODAC voting members who participated in the July 2010 meeting and "have authored numerous publications regarding breast cancer treatment." Those members are marked with an *.
ODAC Member & Expertise Professional Experience ODAC Term/AdComm Experience
Frank Balis The Louis and Amelia Canuso Family Endowed Chair for Clinical Research in Oncology, Children's Hospital of Philadelphia Professor of Pediatrics, University of Pennsylvania Pediatric
Joined CHOP/U-Penn in 2009 from the National Cancer Institute, where he held a number of positions, including senior clinical investigator in the Pharmacology & Experimental Therapeutics Section, Pediatric Oncology Branch, and NCI clinical director. CV lists seven research publications co-authored with Genentech witness Joyce O'Shaughnessy ( Baylor-Sammons Cancer Center ), including some breast cancer studies. 5/17/2011-6/30/2014 [New member] Temporary voting member at ODAC's February 2011 review of confirmatory post-marketing studies for accelerated approval drugs. Temporary voting member at the Pediatric Oncology Subcommittee's November 2010 review of pediatric development plans for four anti-cancer agents. Guest speaker at September 2000 Pediatric Oncology Subcommittee meeting on extrapolating adult oncology data to the pediatric population.
Gregory Curt U.S. Medical Science Lead, Emerging Products, AstraZeneca Oncology Clinical oncology Joined AstraZeneca in 2002 as medical director after more than 20 years at NCI, where his roles included clinical director, deputy director for clinical affairs at the Division of Clinical Sciences, and associate director of the clinical oncology program. Co-authored an article in 2000 with Genentech corporate witness Sandra Horning (formerly of Stanford University ) on fatigue in cancer patients. 6/10/2008-10/31/2011 Non-voting industry representative. Participated in both previous ODAC reviews of Avastin in MBC (12/2007, 7/2010). Also participated in ODAC's March 2009 review of Avastin in glioblastoma multiforme, for which the committee unanimously endorsed approval.
Ralph Freedman* Clinical Professor, Dept. of Gynecologic Oncology, University of Texas M.D. Anderson Cancer Center Gynecologic oncology Faculty member at M.D. Anderson since 1977; previously served as chief and director, immunology and molecular biology research, in the Dept. of Gynecologic Oncology. Published extensively on endometrial, ovarian and cervical cancers. CV lists three published articles and two book chapters on breast cancer and related issues; also served as series editor for two breast cancer monographs. Co-authored article on clinical trial endpoints in ovarian cancer with Horning and CDER Office of Oncology Drug Products Director Richard Pazdur in 2007; co-authored a chapter on gestational trophoblastic tumors in a 1996 book edited by Pazdur when the latter was at M.D. Anderson. 5/21/2009-6/30/2012 Voted to withdraw Avastin's MBC indication in July 2010, based in part on "substantial defects" in original E2100 study.
Jean Grem* Professor of Medicine, Dept. of Internal Medicine, Section of Hematology Oncology, University of Nebraska Medical Center Hematology/oncology Joined UN faculty in 2003 from NCI, where she worked in a variety of capacities since 1986, most recently as head of the gastrointestinal malignancies section at the Center for Cancer Research's Cancer Therapeutics Branch. Published extensively on colorectal and gastrointestinal cancers. CV lists seven research publications, book chapters and review articles on breast cancer. 5/5/2008-6/30/2011 Voted to withdraw MBC indication in July 2010; did not think median PFS benefit of 0.9 months seen in AVADO with docetaxel was clinically meaningful, particularly given Avastin's substantial toxicities; also cited cost as an issue, while conceding it is not within ODAC's purview.
William Kevin Kelly Professor of Medical Oncology and Urology, Thomas Jefferson University Medical oncology Joined Thomas Jefferson in 2010 as director of the solid tumor division. Previously spent five years at Yale School of Medicine, where he was medical director of the Clinical Research Service and director of the Solid Tumor Clinical Investigation Program at Yale Comprehensive Cancer Center . Published extensively on prostate cancer research. Served as principal investigator of CALGB 90401, a Phase III study of Avastin in hormone-refractory prostate cancer that missed its primary endpoint of overall survival. 5/21/2009-6/30/2012 Did not participate in July 2010 review of Avastin in MBC.
Patrick Loehrer* Director and Associate Dean for Cancer Research, Melvin and Bren Simon Cancer Center, Indiana University Medical oncology Faculty member since July 1983 and currently holds the post of H.H. Gregg Professor of Oncology. Publications heavily focused on germ cell tumors and cancers of the testes, lung, endothelium and pancreas. Studies include a Phase II trial of bevacizumab in patients with recurrent thymoma or thymic carcinoma. CV lists seven research publications and four abstracts/letters/reviews related to breast cancer treatment and screening; also served as PI for a breast cancer prevention trial. Co-authored chapters on testicular cancer in books about cancer management edited by Pazdur. Collaborated with Genentech witness Howard Burris III (Sarah Cannon Research Institute) on pancreatic and colorectal cancer studies. 5/21/2009-6/30/2012 Voted to withdraw MBC indication in July 2010 because bevacizumab's activity in breast cancer is not sufficiently clarified. Suggested the sponsor look at baseline symptoms to see if patients experienced a clinical benefit in the form of decreased pain, increased performance status or another surrogate marker. Encouraged the sponsor to identify a patient population that may benefit.
Brent Logan Assistant Professor of Biostatistics, Medical College of Wisconsin Biostatistics Faculty member since 2001; also holds the post of adjunct associate professor in the Department of Mathematics at the University of Wisconsin-Milwaukee. Research includes numerous publications involving hematopoietic cell transplantation studies. 2/24/2010-6/30/2013 Voted to withdraw MBC indication in July 2010 in light of the reduced magnitude of PFS benefit seen in the AVADO and RIBBON1 studies compared with the E2100 trial.
Virginia Mason Executive Director, Inflammatory Breast Cancer Research Foundation Oncology nursing 15-year career in nursing before becoming executive director in 2003; also a cancer survivor. 7/1/2007-6/30/2011 ODAC's consumer representative. Lone vote in favor of retaining the MBC indication at July 2010 meeting; believed current labeling that describes lack of data on symptom improvement and survival benefit is sufficient to allow patients and physicians to make a risk/benefit decision. Voted against initial approval for MBC at ODAC's December 2007 review. Voted for approval in glioblastoma multiforme at March 2009 meeting.
Mikkael Sekeres Associate Professor of Medicine, Cleveland Clinic Taussig Cancer Institute Medical Oncology On faculty at Cleveland Clinic since 2003, when he joined from Harvard; currently serves as director of the leukemia program. Published research focuses primarily on myelodysplastic syndromes, leukemia and lymphoma. 5/21/2009-6/30/2012 Voted to withdraw MBC indication in July 2010; said the AVADO and RIBBON1 studies, at best, confirmed a PFS advantage with bevacizumab but fell short of defining the degree of clinical benefit.
Margaret Tempero Deputy Director, Director of Research Programs, Univ. of Calif.-San Francisco Helen Diller Family Comprehensive Cancer Center Hematology/oncology Joined UCSF in 2000 from the faculty of the University of Nebraska, where she was deputy director of UNMC/Epply Cancer Center and chief of oncology and hematology and the Omaha V.A. Medical Center; former president of American Society of Clinical Oncology. Research areas include pancreatic and gastrointestinal cancers, including Phase I/II studies of bevacizumab for pancreatic cancer, neuroendocrine tumors and advanced solid tumors. 5/5/2008-6/30/2011 Did not participate in ODAC's July 2010 meeting or the March 2009 review of bevacizumab for glioblastoma multiforme.
Julie Vose Chief, Division of Hematology/Oncology, University of Nebraska Medical Center Hematology/oncology UNMC faculty member since 1990; holds the title of Neumann M. and Mildred E. Harris professor and formerly served as vice chairman of the Dept. of Internal Medicine. Published extensively on clinical trials for leukemia and lymphoma. Collaborated with Burris and Horning on studies of treatments for non-Hodgkin's lymphoma. 5/17/2011-6/30/2014 [New member] Member (1994-1997) and chair (1996-1999) of FDA's Biological Response Modifiers Advisory Committee. Received a waiver to participate as a temporary voting member in ODAC's May 2009 review of Arzerra (ofatumumab) for chronic lymphocytic leukemia. Temporary voting member in ODAC's May 2008 review of Promacta (eltrombopag) for chronic idiopathic thrombocytopenic purpura; voting consultant at ODAC's June 1998 review of Ontak(denileukin) for cutaneous T-cell lymphoma; and ODAC guest expert for December 1997 review ofProleukin (aldesleukin) in metastatic melanoma.
Wyndham Wilson* Senior Investigator and Chief, Lymphoma Therapeutics Section, Metabolism Branch, Center for Cancer Research, National Cancer Institute Lymphoma/neurobiology On staff at NCI since 1984 and has served in a variety of roles, including chief of the lymphoma clinic since 1997. Published research is heavily focused on lymphoma and leukemia, but he has collaborated with O'Shaughnessy on four published articles involving metastatic breast cancer. 5/5/2008-6/30/2012 Current ODAC chairman. Voted to withdraw MBC indication in July 2010 because the "totality of the data" did not support efficacy; suggested further studies to explore whether there is a subset of patients with an "angiogenesis signature" that may benefit from the drug. Supported approval for glioblastoma multiforme at March 2009 meeting.
Avastin Fight Song

Composer and performer, Andrew Katz, NYC

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