In a stunning turn for its oncology drug, rociletinib (CO-1686), Clovis Oncology Inc. reported that the FDA wants additional clinical data to evaluate the efficacy of the 500 mg and 625 mg dose groups in the treatment of non-small-cell lung cancer (NSCLC) patients with initial activating epidermal growth factor receptor (EGFR) mutations, as well as the dominant resistance mutation T790M. The agency's request came during a regularly scheduled midcycle communication meeting last week.
Patrick Mahaffy, Clovis president and CEO, said the company expected to provide the information to the FDA by Monday's close of business.
But that was just the first of several damaging revelations from Clovis, of Boulder, Colo. The company