CDER challenges Oncopeptides’ appeal over Pepaxto withdrawal
FDA’s Center for Drug Evaluation and Research is objecting to Oncopeptides’ appeal of the agency’s request to withdraw its cancer drug Pepaxto.
Pepaxto was first granted accelerated approval in February 2021 for the fifth-line treatment of multiple myeloma in combination with dexamethasone. However, the FDA halted Oncopeptides’ confirmatory trials in July of that year after noting an increased risk of death among patients who took a Pepaxto and dexamethasone combination. Oncopeptides initially indicated it would withdraw the drug from the market, but quickly reversed course.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.