Accelerated Approval Submission On The HORIZON For Oncopeptides’ Melflufen
US FDA says Phase II HORIZON data in relapsed triple-class refractory multiple myeloma can support NDA; Oncopeptides aims for submission Q1 2020.
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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.
Oncopeptides AB’s melflufen (Pepaxto) has met the primary PFS endpoint in the Phase III OCEAN study, designed to extend its reach into earlier-stage multiple myeloma patients, but overall survival data favors the comparator in patient subgroups, and melflufen in others, leading to regulators pausing clinical trials to review the results.
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