Pazopanib Receives Unanimous FDA Panel Approval Recommendation
The Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration voted unanimously in support of the approval of GlaxoSmithKline’s pazopanib (Votrient), an investigational oral agent. Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma.
The Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration voted unanimously in support of the approval of GlaxoSmithKline’s pazopanib (Votrient), an investigational oral agent. Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma.
The advisory committee made its decision based on phase III pivotal trial data that were presented at the American Society of Clinical Oncology 2009 annual meeting. In its pivotal study, pazopanib was administered orally, once daily. Pazopanib has a broad clinical program across multiple tumor types, but has not yet been approved in any country.
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