FDA committee votes against accelerated approval of Clovis’ rociletinib lung cancer drug

Rociletinib is indicated to treat patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been earlier treated with an EGFR-targeted therapy and have the T790M mutation.

The committee is recommending that the FDA wait for data from TIGER-3 phase 3 clinical trial before making a decision on rociletinib. Patient enrollment for the study is anticipated to be completed in late 2018.

The FDA’s action date is 28 June under the Prescription Drug User Fee Act (PDUFA).

Clovis Oncology president and CEO Patrick Mahaffy said: "We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib.

"We will work with the FDA to evaluate the best path forward as it continues to review our application."

Data from TIGER-X and TIGER-2 clinical trials served as the basis for the US and EU regulatory submissions to treat advanced mutant EGFR T790M-positive lung cancer.

The FDA granted breakthrough therapy designation to rociletinib in May 2014.

Lung cancer is the second most common cancer in the US, with over 200,000 new cases per year.

NSCLC accounts for about 85% of lung cancers, and the five-year survival rate in locally advanced and metastatic patients is 27% and 4%, respectively.