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.