The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program, with a focus on those that are expected to have a major impact on the standard of care – including “Breakthrough”-designated projects and novel treatments.
OCE announced the Orbis pilot at the same time it approved the first application in conjunction with Australian and Canadian regulatory agencies: Eisai Inc.’s Lenvima (lenvatinib) in combination with...
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