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FDA Opts For Full, Rather Than Accelerated, Approval Of GSK’s Votrient In Sarcoma

 
• By Sue Sutter

Despite advisory committee discussion about a possible accelerated approval for pazopanib with a confirmatory study to assess symptom benefit, the agency opted to grant regular approval, as had been requested by GlaxoSmithKline.

FDA’s decision to grant regular approval to GlaxoSmithKline PLC’s Votrient (pazopanib) in advanced soft tissue sarcoma, without the need for additional post-marketing studies, suggests it may have concluded that requiring a confirmatory study to assess symptom benefit would have been difficult to accomplish and not particularly useful.

On April 26, FDA approved pazopanib for treatment of patients with advanced STS who have received prior therapy. The indication...

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