FDA-2023-N-3167-0006_content (3).pdf

Page 3 of 36Oncopep�des AB Melfufen Powder for Solu�on for Infusion Module 1.11.3: Clinical Informa�on Amendment 3 1. Execu�ve summary The interpreta�on of the results of the melflufen study OP-103 is challenging due to the dissociated PFS and OS results with significantly heterogenic OS HRs across the age-spectrum. This dissocia�on between PFS and OS is caused by pomalidomide OS effect…

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