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 www.fameds.org.

CONTACT: Terry Kalley

248-761-8215

SOURCE Freedom of Access to Medicines

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