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Pepaxto Withdrawal Dispute: Oncopeptides Details Plans For New Studies

 
• By Sue Sutter

An observational single-arm study and a dose-optimization study are planned if the FDA does not withdraw accelerated approval of the multiple myeloma drug, Oncopeptides says. If an additional confirmatory trial is needed, company suggests two different approaches, one of which is almost a repeat of the OCEAN study, the results of which remain in dispute.

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Oncopeptides' confirmatory study proposals include a "repeat" of the OCEAN trial, albeit with a more limited patient population. • Source: Shutterstock

Oncopeptides AB plans to conduct a 100-patient, single-arm study and a 40-patient, dose-optimization study of its multiple myeloma treatment Pepaxto (melphalan flufenamide, or melflufen) but believes the accelerated approval drug should remain on the US market while these trials are carried out.

If these proposed studies are not considered sufficient to further verify clinical benefit, the company said it would like to align with the Food and Drug Administration on a plan for a new Phase III confirmatory trial and suggests two possible approaches

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