The U.S. Food and Drug Administration (FDA) has invited Amgen to participate in a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) on November 30, 2010. The Subcommittee will hear presentations from four different companies about the pediatric development plans for their respective products, including Amgen’s denosumab. Based on the information presented, the Subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate.
Amgen is committed to careful consideration and study of the safety and efficacy of its products for use with pediatric patients. Amgen looks forward to gaining the perspective of the Subcommittee on the potential use of denosumab in pediatric settings. Specifically, Amgen wishes to discuss our post-marketing commitments to study the prevention of bone complications in pediatric cancer patients. In addition, Amgen would like to discuss its exploratory program in giant cell tumor of bone. Finally, Amgen will highlight proposals from external investigators to evaluate the agent in primary bone tumors such as osteosarcoma and Ewing’s sarcoma.
Amgen welcomes the opportunity to discuss the development of denosumab in pediatric oncology patients and to further collaboration with the Agency to further define the utility of denosumab in pediatric populations.
The materials are now available at the FDA website.
CONTACT: Amgen, Thousand Oaks
Lisa Rooney: + 1 (805) 447-6437 (media)
Arvind Sood: +1 (805) 447-1060 (investors)