BioCentury
ARTICLE | Regulation

Endangered TIGER?

Handicapping rociletinib's future in NSCLC

April 25, 2016 7:00 AM UTC

Comments from an FDA panel suggest there may still be a path to market for rociletinib from Clovis Oncology Inc. in NSCLC, albeit a much narrower one. But that depends on the company taking advice from the agency - which briefing documents suggest it has not always done to date.

Finding a path to market also may depend on modifications to the ongoing TIGER-3 trial, especially if physicians or patients are reluctant to participate given the panel's questions about dosing and toxicity, and the availability of newer agents...