Navigation Links
Breast Cancer Patients and Families Decry FDA Panel Vote to Remove Life Saving Drug From Approved List

SILVER SPRING, Md., June 29, 2011 /PRNewswire-USNewswire/ -- Breast cancer patients and their families expressed extreme disappointment at today's Food and Drug Administration (FDA) decision to remove the anti-cancer drug Avastin from the approved medication list for treatment of late stage breast cancer.

Terry Kalley, founder of the Freedom of Access to Medicines (FAMEDS), condemned the decision, saying, "While this vote is disappointing, it wasn't unexpected, because of the six voting members on today's panel, five of them are already on record as opposing the continued use of Avastin for treatment of breast cancer."

Kalley, whose wife has late stage breast cancer and has been immensely helped by Avastin, criticized the FDA panel's makeup as lacking expertise in the area of breast cancer.

"This panel that has passed judgment on a life or death matter with breast cancer should have been made up of breast cancer specialists and oncologists, but it had zero breast cancer specialists or oncologists on it.  But we had breast cancer oncologists testifying on our behalf yesterday to keep patient access to Avastin," Kalley said.  "Additionally, this panel was handpicked by FDA Director of the Office of Oncology Products, despite rules that the panel must be independent of him.  Nothing in this panel's process seems impartial or fair."

Kalley pointed out that the FDA dismissed anecdotal evidence when listening to super-responding patients give their stories of survival, but then later used anecdotal evidence to help make its case against using Avastin for breast cancer patients.  He asked FDA Commissioner Margaret Hamburg, who will make the final decision on Avastin, to continue allowing breast cancer patient use of the medication.

"We appeal to FDA Commissioner Margaret Hamburg to correct this grave injustice and do the right thing by extending the label for Avastin to provide continued coverage for metastatic breast cancer," Kalley said.

For more information on FAMEDS and the stories of breast cancer Avastin patients, go to

CONTACT: Terry Kalley


SOURCE Freedom of Access to Medicines
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Breast Cancer Patients and Families Stand Up To FDA
2. Ventana Medical Systems, Inc. Receives FDA Approval for the First Fully Automated Diagnostic Assay for HER2 Gene Status Determination in Breast Cancer Patients
3. FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment
4. Data from Clinical Studies of bioTheranostics CancerTYPE ID® and Breast Cancer Index(SM) Molecular Diagnostic Tests Presented at ASCO 2011 Annual Meeting
5. Precision Therapeutics Demonstrates Utility of Multi-Gene Predictors in Predicting Chemotherapy Response for Breast Cancer Patients
6. NKTR-102 Demonstrates Sustained Clinical Benefit in 46% of Patients with Metastatic Breast Cancer in Data Presented at 2011 American Society of Clinical Oncology Annual Meeting
7. Genomic Health Presents Ten New Studies in Breast, Colon and Prostate Cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting
8. MD Anderson and Biocept Scientists to Present Poster at ASCO on Disseminated Tumor Cells (DTCs) in Bone Marrow and Circulating Tumor Cells (CTCs) in Blood in Early Stage Breast Cancer Patients
9. The World Leader in Molecular Breast Imaging to Premiere Largest Detector in the Industry
10. Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients
11. Nexavar in Combination with Chemotherapy Improves Progression-Free Survival in Patients with Advanced Breast Cancer in Phase 2 Study
Post Your Comments:
(Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Japanese ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/26/2015)... November 26, 2015 ... universitetssjukhus ser potential att använda SyMRI för ... för patienter med multipel skleros (MS) ... med SyntheticMR AB för att kunna använda ... sjukhuset. Med SyMRI kan man generera flera ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... TyloHelo Inc , ... accessories. , Sauna accessories help improve the bather experience in the sauna, and ... styles for the purist looking for simplicity in design to accessories that encourage ...
(Date:11/25/2015)... ... November 25, 2015 , ... According to an article published November ... more widely heralded as a breakthrough for performing hernia repairs. The article explains that ... surgery is that it can greatly reduce the pain that a patient might otherwise ...
(Date:11/25/2015)... ... , ... The McHenry County law firm of Botto Gilbert Lancaster, PC ... J. Botto and Alex C. Wimmer. Attorneys Botto and Wimmer represented the claimant David ... 130884WC. , According to court documents, Adcock testified that on May 10, 2010 he ...
(Date:11/25/2015)... ... 25, 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, ... 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final ... has been a treasured tradition for numerous families in the Evanston community. Over ...
(Date:11/25/2015)... ... November 25, 2015 , ... In honor ... Periwinkle Pioneers, individuals and groups responsible for advancing care for pulmonary hypertension (PH) ... nominated by the public, will receive special recognition throughout 2016 as part of ...
Breaking Medicine News(10 mins):