Rx For Immuno-Oncology Excess? Top US FDA Cancer Officials Take On Development ‘Wild West’
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.
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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.
Lilly/Innovent Experience Show Hurdles Remaining For Chinese PD-1 Inhibitors
China has fielded several homegrown checkpoint inhibitors, using lower cost as an argument for the US market, but sintilimab – a key test case – has underscored FDA skepticism.
Broader Horizons For Advanced Biotech In 2022: New Targets, Settings For IO, Cell And Gene Therapy
US FDA’s user fee goal calendar for 2022 already contains 45 applications for novel agents featuring a wide array of biologics, from cell therapy in cancer and hematology to bispecifics and new immuno-oncology targets that could move the field beyond PD-1/L1.