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Pharmaceutical industry

Clovis Oncology's Rociletinib Faces Delays in FDA Approval Review

Strategic Insights

— 2 min read

Clovis Oncology's struggle to bring its targeted lung cancer drug rociletinib to market has taken a significant hit as the US FDA has requested additional clinical data, delaying the approval review and putting Clovis further behind rival AstraZeneca. The FDA's decision is largely due to revised and lowered response rates in lung cancer patients treated with rociletinib, which have fallen below previously disclosed figures. Clovis had hoped to secure approval for rociletinib by March 30, 2016, but the delay, combined with AstraZeneca's recent approval of Tagrisso, a competing lung cancer drug, has severely impacted Clovis's prospects.

Key Takeaways:

  • The US FDA has requested additional clinical data on Clovis Oncology's rociletinib, a targeted lung cancer drug, delaying the approval review and putting the company behind rival AstraZeneca.
  • The FDA's request is due to revised and lowered response rates in lung cancer patients treated with rociletinib, which have fallen below previously disclosed figures of 28% and 34% for the 500 mg and 625 mg doses, respectively.
  • The FDA has asked for updated efficacy data on the rociletinib doses, which will be provided to the agency by the end of Monday.
  • The delay in approval has significant implications for Clovis, which had hoped to secure rociletinib's approval by March 30, 2016.
  • AstraZeneca's recent approval of Tagrisso, a competing lung cancer drug, has further exacerbated Clovis's problems, as FDA approved Tagrisso based on a clinical trial demonstrating a 59% overall response rate.
  • Both Clovis's rociletinib and AstraZeneca's Tagrisso are designed to target non-small cell lung cancer containing the genetic mutation T790M, which renders tumors resistant to treatment with drugs like Roche's Tarceva.

Statistics:

  • Clovis's shares are down 59% to $40.51 in Monday's pre-market trading.
  • The FDA's request for additional data is a significant setback for Clovis, with the company's prospects for approval now uncertain.
  • AstraZeneca's Tagrisso has been approved with a 59% overall response rate in clinical trials.
  • The T790M mutation occurs in approximately 15-20% of non-small cell lung cancer patients, who may benefit from treatment with rociletinib or Tagrisso.

Sources:

  • "Clovis Oncology shares dive on delays with FDA approval review", Bloomberg, [www.bloomberg.com](http://www.bloomberg.com)
  • "Clovis Oncology's Rociletinib Faces FDA Review Delay", The Wall Street Journal, [www.wsj.com](http://www.wsj.com)
  • "FDA Approves AstraZeneca's Tagrisso for Lung Cancer", The New York Times, [www.nytimes.com](http://www.nytimes.com)

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