Navigation Links
Breast Cancer Patients and Families Decry FDA Panel Vote to Remove Life Saving Drug From Approved List
Date:6/29/2011

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 www.fameds.org.

CONTACT: Terry Kalley

248-761-8215


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... 2016 ReportsnReports.com adds "Chronic ... that provides an overview on therapeutic pipeline of ... stages, therapeutics assessment by drug target, mechanism of ... type, along with latest updates, and featured news ... involved in the therapeutic development for Chronic Cough ...
(Date:5/24/2016)... 24, 2016   ... primären Endpunkte und demonstriert Ebenbürtigkeit bei ... ‚ausgezeichneter plus guter , ...      (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a ) ... positive Daten von der MORA-Studie der Phase III ...
(Date:5/24/2016)... ARANZ Medical  Ltd a specialist ... has been named the Coretex Hi-Tech Emerging Company of the ... Dr Bruce Davey , CEO of ARANZ Medical says, ... good to be recognised for the work we are doing ... in 35 countries around the world from Sub-Saharan Africa through ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... There are many ways to cook a hot ... suggests that Americans prefer their dogs straight off the grill. Of the 90 percent ... favorite way to cook a hot dog, far outpacing other cooking methods such as ...
(Date:5/26/2016)... ... , ... Connor Sports, through its Connor Cares initiative, will continue ... Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career and ... forms and levels of the game, Connor Sports has committed to a significantly increased ...
(Date:5/26/2016)... ... ... MadgeTech will be showcasing its line of data logging products , ... MadgeTech headquarters. With products sold in more than 100 countries around the world, MadgeTech ... , In 2012, NASA strategically set up 17 RHTemp101A MadgeTech data loggers around ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the ... Insurance is sharing tips to make sure your family and vehicle are ready ... Safety Council, there may be 439 deaths and an additional 50,500 serious injuries from ...
(Date:5/26/2016)... Rafael, CA (PRWEB) , ... May 26, 2016 ... ... will be offering campers a multitude of activities from daily practices, arts & ... self-confidence. , Camp Directors Amber East-D’Anna and Christy Evans have combined backgrounds in ...
Breaking Medicine News(10 mins):