Clovis Oncology Falls 7%: Here's What You Need To Know

Clovis Oncology IncCLVSposted briefing documents ahead of the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss accelerated approval of the New Drug Application (NDA) for rociletinib. The FDA recommended in its briefing documents the inclusion of a boxed warning on Clovis' drug, rociletinib. "FDA recommends the inclusion of a Boxed Warning for the risk of QTc prolongation leading to Torsades de pointes," the FDA said in its document. "FDA also recommends that labeling describe ECG monitoring of QTc interval at baseline and periodically while receiving treatment with rociletinib. FDA also recommends inclusion in labeling of Warning and Precautions subsections for QTc prolongation, hyperglycemia, interstitial ling disease/pneumonitis, pancreatitis, and cataracts." The Street's biotech expert, Adam Feuerstein stated that the FDA's briefing documents "confirms - and amplifies - all the bad stuff we knew about the drug already," including the company misleading investors about the drug's benefit to risk profile. "Clovis now says the confirmed response rates to the 500 mg and 625 mg doses of rociletinib are 28% and 34%, respectively," Feuerstein argued in late 2015. "Those are lower than the response rates previously disclosed by Clovis." Feuerstein also suggested that Clovis may actually be "better off" if the FDA rejects the drug.