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Pepaxto’s Accelerated Approval In Myeloma May Sink On OCEAN Trial's Adverse Survival Data

Executive Summary

US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.

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US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

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Istodax’s Lymphoma Accelerated Approval Indication Falls Victim To Failed Confirmatory Trial

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