An FDA advisory panel voted 12-1 last week against recommending accelerated approval to Clovis Oncology’s lung cancer candidate rociletinib.
With its vote, the Oncologic Drugs Advisory Committee recommended that the agency wait for more data from an ongoing Phase 3 trial before rendering a decision. Still, data from the study may not entirely quell concerns, panel members suggested.
“There are too many unanswered questions that need to be addressed,” said William Figg, who heads the Clinical Pharmacology Program for the National Cancer Institute’s Center for Cancer Research. He also expressed skepticism over whether the ongoing clinical trial could answer all of the questions.