Spectrum’s Delay In Starting Confirmatory Trial Of Poziotinib Troubles US FDA

Ahead of advisory committee review, agency cites poziotinib’s marginal anti-tumor activity, high rates of toxicity, and lack of dose optimization. Company seeks accelerated approval but was given standard review.

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FDA panel to weigh the benefits and risks of Spectrum's lung cancer drug poziotinib • Source: Shutterstock

The US Food and Drug Administration is concerned that Spectrum Pharmaceuticals Inc. had not begun enrolling patients in a confirmatory trial of its targeted non-small cell lung cancer drug Pozenveo (poziotinib) as of the end of July.

The company is seeking accelerated approval of the drug. FDA said postmarketing studies should be underway at the time of...

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