Rociletinib regulatory update

Clovis said the rate of confirmed responses to rociletinib for non-small cell lung cancer (NSCLC) was lower than previously reported unconfirmed response rates that served as the primary basis for an NDA submission. FDA requested additional data from Clovis, which said it submitted but would constitute as a major amendment and delay FDA’s review timeline beyond rociletinib’s PDUFA date of March 30, 2016. The NDA is seeking approval to treat NSCLC in patients who have the EGFR T790M mutation and have been previously treated with an EGFR-targeted therapy.

Clovis said the agency had requested additional data for the twice-daily 500 and 625 mg rociletinib arms for its efficacy analysis and would focus only on confirmed responses. Clovis said its NDA had contained immature data sets based on both unconfirmed response rates and confirmed response rates; the data sets were updated in a 90-day efficacy update Clovis had submitted at the end of last month. ...