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Clovis Pulls Plug On Rociletinib On Expected FDA Rejection

 
• By Donna Young

Clovis Oncology Inc. on May 5 disclosed the FDA notified the company to expect its application for its experimental lung cancer drug rociletinib to be rejected – something that was widely expected on Wall Street after the firm failed in April to convince a federal panel of experts to back the medicine. Clovis, which is cutting its staff by 35% in the wake of the FDA's snub, now turns its attention to its investigational ovarian cancer drug rucaparib.

After the markets closed on May 5, Clovis Oncology Inc. fessed up to what Wall Street already anticipated as the inevitable: rociletinib was roadkill – mowed down by the FDA, although the tread marks looked suspiciously like those belonging to AstraZeneca PLC's competing lung cancer drug Tagrisso (osimertinib).

In its quarterly earnings call, Clovis disclosed it was notified by the FDA to expect a complete response letter instead of the accelerated approval the firm was eyeing to gain by its June 28 Prescription Drug User Fee Act (PDUFA) action date for rociletinib as a treatment for patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic

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