US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch
Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.
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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.
Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.
FDA’s “Project Optimus” draft guidance on dose optimization is in the works. Until then, randomized dosing studies need to be an IND-level conversation.