1. Pink Sheet

Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot

 
• By Bridget Silverman

Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.

The hands of the captain and a steering wheel boat port services

Genentech Inc. is at the forefront of sponsors vying to use the US FDA Oncology Center of Excellence’s Real-Time Oncology Review (RTOR) pilot program, as the Roche subsidiary announced a second application being reviewed under the speedy new pathway.

A supplemental new drug application (sNDA) for a new indication for Venclexta (venetoclax) – use in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions – is being evaluated under the RTOR pilot,

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