12 April 2016 - It looks likely that Clovis Oncology’s non-small cell lung cancer drug rociletinib will hit a major setback in its quest for approval after failing to win the support of US FDA advisors.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against approving the drug for patients with mutant epidermal growth factor receptor (EGFR) NSCLC who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.

The final word on drug still lies with the FDA, which doesn’t always follow the advice of its advisory committees. However, given the regulator’s concerns over the drug’s safety and efficacy, a rejection does currently seem likely before the target action date of 28 June 2016.

For more details, go to: http://www.pharmatimes.com/Article/16-04-12/FDA_advisors_vote_against_Clovis_rociletinib.aspx