Clovis Bags Rociletinib After FDA Rejection

Source: OneLive

May 13, 2016

Clovis Oncology has announced that it will stop clinical development of rociletinib, its once-promising EGFR inhibitor for the treatment of patients with non–small cell lung cancer.

The FDA has notified the Colorado-based drugmaker of an upcoming complete response letter -- meaning the agency will not approve Clovis' NDA based on available data.

Clovis also reported that it is under federal investigation surrounding erroneous rociletinib- data that was posted in the New England Journal of Medicine last year.

Read the OneLive article

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