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OBR OncologyFDA Rejects HER2 Exon 20-Targeted Therapy for Lung Cancer

Spectrum Pharmaceuticals would need to study the drug further, including generating data from a randomized controlled trial, according to the release. Spectrum responded by stating that it would “de-prioritize poziotinib program activities, effective immediately.” The decision comes after the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the drug’s demonstrated clinical benefit did not outweigh its risks.

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