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BioWorld - Wednesday, June 24, 2026
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Home » One trial, two regulators, two opinions on Oncopeptides drug
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One trial, two regulators, two opinions on Oncopeptides drug

Sep. 14, 2023
By Mari Serebrov
Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.
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