FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

SEC May Take Civil Action Over Abandoned Clovis Lung Cancer Drug

April 17, 2018
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The Securities and Exchange Commission is considering a civil enforcement action or administrative proceeding against Clovis Oncology for its failure to accurately disclose response rates in clinical trials for its lung cancer drug rociletinib.

The potential SEC action is in response to a November 2015 press release by the company noting the FDA had asked for additional data and that confirmed patient response rates in clinical trials were lower than expected.

The company later abandoned the drug candidate. However, the SEC may still take action against the company for failure to disclose the difference between confirmed and unconfirmed response rates.

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