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.

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

More from Review Pathways

More from Pathways & Standards