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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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.
Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.
Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.