Clovis tanks as investigational lung cancer drug rociletinib is set for a delay

17 November 2015

US personalized cancer therapy specialist Clovis Oncology (Nasdaq: CLVS) yesterday revealed that, as a result of its regularly scheduled Mid-Cycle Communication Meeting held last week with the US Food and Drug Administration, there is likely to be a delay for its lead clinical candidate rociletinib.

The agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. The news sent Clovis shares plunging 69.6% to $30.24 by close of trading on Monday.

The company anticipates that the review of this additional information will result in a delay of a potential approval. This additional review could lead to an extension of the Company’s March 30, 2016 Prescription Drug User Fee Act (PDUFA) date.

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