FDA’s Oncologic Drugs Advisory Committee to Review Two New Drug Applications for Sarcoma on Tuesday, March 20, 2012
An Important Day for People with Rare Cancers like Sarcoma
ANN ARBOR, Mich., March 19, 2012 /PRNewswire-USNewswire/ — SARC, Sarcoma Alliance for Research through Collaboration, a non-profit sarcoma research collaborative group, announced that on Tuesday, March 20, 2012, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will review two New Drug Applications submitted by two pharmaceutical companies that are seeking FDA approval for their drugs for the treatment of sarcoma. Sarcoma is a rare cancer that occurs in the bones and the soft tissues that connect the bony skeleton, like muscle and fat. In 2012, approximately 14,000 new cases will be diagnosed, accounting for less than 1% of adult cancers and approximately 15% of childhood cancers. New and better treatments are needed for the people who are diagnosed with sarcomas.
This marks an important day for not only the patients but the physician scientists and clinicians who study these diseases. Shreyaskumar Patel, M.D., Chair of the SARC Clinical Research Committee and Professor, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, stated, “The sarcoma community of patients and providers is very excited about the pharmaceutical industry’s recent interest in new drug development for these rare group of diseases. It has been a very long time since a new drug has been approved for the non-GIST soft tissue sarcomas. We anxiously await the results of the FDA’s review process.” Denise Reinke, MS, NP, President of SARC, stated, “SARC’s mission is to identify new treatments and make them available for sarcoma patients. Clearly, having two new drugs up for review by the FDA is an important step aligned with our mission.”
The Center for Drug Evaluation and Research (CDER) provides a free webcast of this meeting. The meeting first application will be discussed during the morning session beginning at 8 a.m. EDT. Following a one hour break, at 1 p.m. EDT the second application will be reviewed. The webcast can be accessed at the following web address: https://collaboration.fda.gov/odac320/. At the access page, sign in as a guest. No password is required.
SARC is a not-for-profit consortium representing physician clinician/scientists who have common interest in developing new and effective treatments for patients diagnosed with sarcoma. SARC’s mission is to provide the collaborative platform needed to support research for the prevention, treatment and cure of sarcoma. For additional information, please visit our website (www.sarctrials.org).