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| FDA |
"Previously, certepetide was granted ODD by the FDA for use as a potential therapeutic option in patients with malignant glioma in August 2023; rare pediatric disease designation in osteosarcoma in March, 2024; and ODD for osteosarcoma in April 2024. Additionally, the agent received orphan drug designation for pancreatic cancer by the European Medicines Agency’s Committee for Orphan Medical Products in October 2023, and fast track designation from the FDA in this disease setting.
"Patients in the first-line cohort will receive 1500 mg of intravenous (IV) durvalumab every 21 days plus 25 mg/m² of IV cisplatin and 1000 mg/m² of IV gemcitabine on day 1 and 8 every 21 days for 8 cycles, then every 28 days for additional cycles. In the second-line cohort, patients will receive FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) every 14 days. These respective regimens will be administered alongside either placebo or 3.2 mg/kg of IV certepetide as a slow push over 1 minute. The study’s primary end point is the incidence of adverse effects."
Check the article to learn more about this ODD, including citations and footnotes.
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