Washington Briefs:

Letter to FDA Regarding ESAs:

(sent via email)

December 21, 2007

Richard Pazdur, M.D., F.A.C.P.

Director

Office of Oncology Drug Products

Center for Drug Evaluation and Research

White Oak CDER Office Building 22

10903 New Hampshire Ave.

Silver Spring, MD 20993

Dear Dr. Pazdur,

Thank you very much for meeting with patient groups on November 28, 2007 to listen to our concerns and questions about erythropoiesis stimulating agents.  We were glad to hear from Amgen that FDA plans to hold an Oncology Drug Advisory Committee (ODAC) meeting in early 2008.

We think it is imperative that the FDA include detailed presentations in the meeting which cover:

• A review of information presented at the May 10, 2007 ODAC;
• An update on information which has become available since May 10;
• A progress report on new and proposed trials, including:

• Detail about trial design including specific hypothesis, entry criteria, data elements and endpoints, along with the FDA response to the proposed trial designs;
• Trial locations;
• Trial sponsors, including the specific  identification of who will own the data;
• Detail about which basic research questions need to be addressed, and what, if any, progress has been made toward answering those questions; and
• Trial and research timelines, including interim check points if appropriate.

We are greatly appreciative of FDA’s effort to shed light on these important safety issues.

Thank you,

American Cancer Society

American Cancer Society Cancer Action Network (ACS CAN)

C3: Colorectal Cancer Coalition

Lung Cancer Alliance

Marti Nelson Cancer Foundation

Ovarian Cancer National Alliance