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Home » FDA’s ODAC Deems Sotorasib’s Confirmatory Trial Too Troubled to Be Interpreted
FDA’s ODAC Deems Sotorasib’s Confirmatory Trial Too Troubled to Be Interpreted
Amgen’s open-label confirmatory study of its lung cancer drug Lumakras (sotorasib) had too many data integrity problems to effectively show that the drug is an improvement over the standard-of-care chemotherapy docetaxel, according to the Oncologic Drugs Advisory Committee (ODAC), which met Thursday.