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Cancer Network

Following discussion with the FDA, INN melphalan flufenamide has been withdrawn from market in the United States based on data from the phase 3 OCEAN study.

  • Melflufen was withdrawn from the market by its maker Oncopeptides, in advance of a FDA meeting where its fate was going to be decided. This follows overall survival data from its confirmatory OCEAN trial (Pom-dex versus melflufen-dex).

    Melflufen’s story is a very sobering reminder of hype in oncology, poor trial design and bad media reporting. I want you to think of how melflufens news was reported in the month following the International Myeloma Workshop. I want you to ponder over how major oncology news articles and social media handled the news. A post-hoc unplanned subgroup analysis was celebrated. Patients and investors alike were misled. We have to be more responsible with how we present data. We have to call failures what they are. Could melflufen have suceeded if only patients without prior ASCT were recruited? Probably. But then those are the patients who do well with melphalan or any other chemotherapy anyways. Would we ever know whether its better than any other alkylator? The melflufen story calls for some earnest self-reflection, but if one judges from our history of hype, trial designs intended to seek the broadest approval possible, and irresponsible media reporting, lessons learn from this will likely be short-lived.