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

 
• By Brenda Sandburg

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

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