Amgen to Participate in Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
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 (PODAC) on November 30, 2010.
In the meeting, information will be presented regarding pediatric development plans for four products, including denosumab, that were either recently approved by FDA or, are in late stage development for an adult oncology indication. 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.
The PODAC meeting will include an open discussion between the Pediatric Oncology Subcommittee Members, the FDA, and participating sponsor companies. No formal committee vote is expected.
Participation in this meeting is unrelated to FDA review of the pending application for denosumab in the reduction of skeletal-related events (SREs) in advanced cancer patients with bone metastases. This indication is currently being reviewed as a Priority Review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2010.
CONTACT: Amgen, Thousand Oaks
Christine Regan: + 1 (805) 447-5476 (media)
Arvind Sood: +1 (805) 447-1060 (investors)