All posts from Benzinga
Benzinga in Benzinga,

Clovis Oncology Falls 8%: Here's What You Need To Know

Shares of Clovis Oncology Inc lost more than 8 percent on Friday after the company confirmed that the FDA posted 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."

Related Link: VRX Memo: Addyis Third-Party Sales Force To Be Cut When Contract Ends April 15, Planning Sales Effort Re-Launch

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 percent and 34 percent, 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.

Read more: