FDA Actions, In Brief

FDA ended the week with a flurry of activity, issuing a “complete response” letter, cancelling an advisory committee and approving several drugs.

FDA’s decision to grant regular, rather than accelerated, approval for GlaxoSmithKline PLC’sVotrient (pazopanib) in advanced soft tissue sarcoma suggests reviewers may have concluded that requiring a confirmatory study to assess symptom benefit would have been difficult to accomplish and not particularly useful. The April 26 approval, which did not include any new post-marketing requirements or post-marketing commitments, followed the Oncologic Drugs Advisory Committee’s overwhelming endorsement of pazopanib’s risk/benefit profile in STS Also see "Tale Of Two Sarcoma Drugs: ODAC Gives Nod To GSK’s Votrient, Thumbs Down On Merck/Ariad’s Taltorvic" - Pink Sheet, 20 March, 2012..

At the March 20 advisory committee meeting, FDA officials and panel members discussed the possibility of granting accelerated approval, with...

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