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US FDA's Real-Time Oncology Review Times Coming Into Focus

 
• By Michael Cipriano

With approval of AbbVie Inc./Genentech Inc.'s Venclexta as seventh under RTOR pilot, a roughly two-month median review time under the program could be taking shape.

airport runway under the sun as background

It's been almost a year since then-US Food and Drug Administration commissioner Scott Gottlieb first unveiled the agency's Real-Time Oncology Review (RTOR) pilot last June, and now AbbVie Inc. and Genentech Inc.'s Venclexta (venetoclax tablets) has become the seventh drug to score an approval under the program.

The RTOR pilot is designed to speed the review of certain supplemental oncology indications that appear likely to demonstrate substantial...

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