Project Orbis Nears 30 Approvals In Oncology; Could China Be Added?
A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.
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Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.
China-Only Studies Are ‘Problematic,’ US FDA’s Pazdur Says Ahead Of Lilly/Innovent PD-1 Inhibitor Review
February advisory committee for sintilimab expected to address three main questions about applications relying on single-country data.
Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.