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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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GSK Set To File Votrient For Ovarian Cancer On Strong PFS

Votrient demonstrated a 5.6 month PFS improvement compared to placebo in a Phase III ovarian cancer study presented at the ASCO annual meeting, but no overall survival benefit yet. Nevertheless, GSK believes that the risk/benefit profile is good enough now to support filings in the U.S. and Europe.

GSK Set To File Votrient For Ovarian Cancer On Strong PFS

Votrient demonstrated a 5.6 month PFS improvement compared to placebo in a Phase III ovarian cancer study presented at the ASCO annual meeting, but no overall survival benefit yet. Nevertheless, GSK believes that the risk/benefit profile is good enough now to support filings in the U.S. and Europe.

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