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BioWorld - Monday, March 2, 2026
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Home » Spectrum, Oncopeptides fall on US FDA briefing docs ahead of ODAC meet
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Spectrum, Oncopeptides fall on US FDA briefing docs ahead of ODAC meet

Sep. 20, 2022
By Mari Serebrov
The fate of three cancer drugs, and possibly the future financial health of their sponsors, could be on the line Sept. 22 and 23 as the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) takes a hard look at the safety-efficacy data for Spectrum Pharmaceuticals Inc.’s Pozenveo, Oncopeptides AB’s Pepaxto and Secura Bio Inc.’s Copiktra. First up in the triple-header is Pozenveo (poziotinib), which is seeking accelerated approval as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations confirmed by an FDA-approved test.
BioWorld Regulatory Cancer U.S. FDA

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