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U.S. FDA declines to approve Spectrum Pharmaceuticals“ lung cancer drug

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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Spectrum Pharmaceuticals Inc (SPPI.O) said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug, citing the need for an additional study.

The company now plans to de-prioritize the development of the drug, called poziotinib, and said it was in the process of cutting 75% of its research and development workforce.

Spectrum had 164 employees as of Dec 31, 2021.

The health regulator’s decision is in line with an advisory panel’s recommendation to not approve the drug.

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