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Food & Drug Administration (FDA) casts doubt on the studys claim: FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration
The article cites real-world observational data suggesting nausea severity peaks 1 to 3 hours after the injection for many patients
The accelerated approval was based on a Phase II study of 99 patients in the target population, where Imdelltra led to an overall response rate of 40% and a median duration of response of 9.7 months
In studies, this looks like a period of weight loss followed by a period where weight stays more or less the same
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