- An FDA advisory committee on Tuesday recommended against granting accelerated approval to Clovis Oncology's lung cancer drug. In a 12-1 vote, the panel advised the FDA wait until an ongoing late stage trial wraps up before making a final decision, Reuters reports.
- Last week, FDA staff had questioned the reliance on unconfirmed responses in rociletinib's efficacy data and highlighted several safety concerns.
- Clovis expressed its disappointment in the decision and said it would work with the agency on a way forward. If the FDA follows the advice of the panel, rociletinib won't get another crack at approval until 2019. Patient enrollment in the phase 3 study isn't expected to be completed until late 2018, according to Clovis.
Clovis has been developing rociletinib for second-line treatment of non-small cell lung cancer (NSCLC), but only in the roughly 15% of patients whose cancer is characterized with mutated epidermal growth factor receptors.
The company was aiming to win accelerated approval from the FDA, which would have allowed conditional marketing of rociletinib while Clovis continues its Phase 3 trial. However, after a negative staff review last week and Tuesday's overwhelming vote against approving the drug on the basis of current clinical evidence, that looks unlikely to happen.
Staff reviewers last week had also indicated the drug should be required to carry a "black box" warning if approved, due to safety concerns.
Although the FDA doesn't always follow the recommendations of advisory committees, it usually does. The regulator is set to make a final decision before June 28.
Adding to challenging outlook for the drug, AstraZeneca already has a drug on the market with higher clinical effectiveness. The drug, Tagrisso, won approval from the FDA in November 2015 and would be a direct competitor to rociletinib.
Shares of Clovis fell sharply on the news, but recovered to close down roughly 5% on the day.