Genmab — Maj 2025
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Asia stymies Columvi's expansion
21 May 2025Starglo isn't applicable to a US population, an adcom rules. https://www.oncologypipeline.com/apexonco/node/1334
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De har kun brugt 2 år på STARGLO, og kunne vel nok have fået 3-4 år af FDA til at færdiggøre forsøget. Så den mest oplagte grund er at konkurrence fra ande behandlings regimer bl.a. EPCORE 1+2+4. Er det forkert set at dette er et bragging point for Genmab ?
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Det kan også være derfor, men her siger de det lige ud, “We’re sitting here at the US FDA, and 25 patients were enrolled from the US,” said Daniel Spratt, MD, ODAC member and chairman and professor of radiation oncology at University Hospital Seidman Cancer Center, when explaining the reason why he voted no.
“Another word I kept coming back to was ‘sufficient,’ that sponsors should plan to enroll a sufficient number of US participants,” Ravi A. Madan, MD, ODAC member
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Godmorgen
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Det hører nok med, at dette i nogen grad går tilbage til Covid-perioden og i udgangspunktet har de nok heller ikke antaget, at geografisk fordeling ville kunne være et problem (som antydet mener de vist også forsat, at forskellene i resultater skyldes forskelle i sammensætning af patientgrupperne, men de kan ikke rigtig bevise det med få patienter (9% fra US))
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