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Wednesday 06.20.12

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06/20/12
8 a.m.

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 25184) - Meeting

Subject: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 25184) holds a meeting of the Oncologic Drugs Advisory Committee.

Agenda:

Highlights:

-- Morning: Discuss new drug application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC, for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score of greater than or equal to 3

-- Afternoon: Discuss NDA 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc, for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent

Location: FDA White Oak Campus, Building 31, 10903 New Hampshire Avenue, the Great Room, White Oak Conference Center, Room 1503, Silver Spring, Md.

Participants:

Contact: Caleb Briggs, 301-796-9001, ODAC@fda.hhs.gov

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