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

29 Jul 2021

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.

Ocean — Oncopeptides' melphalan flufenamide could be facing rough seas. • Source: Alamy

An adverse survival trend in the confirmatory trial for a recently approved multiple myeloma drug is once again putting the focus on the US Food and Drug Administration’s use of the accelerated approval pathway.

On 28 July, the agency alerted patients and health care providers to an increased risk of death with Oncopeptides...